Upcoming Product-Specific Guidances for Generic Drug Product Development
Introduction
This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic drug products, including the projected date of PSG publication, as a commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III). Upcoming PSGs for both complex and non-complex products that are planned to be published in the next 12 months are listed (these may be subject to change).
How often does FDA publish new and revised PSGs?
To support generic drug development and generic drug approval, FDA issues new and revised PSGs on a quarterly and as needed basis. These PSGs, including PSGs for both complex and non-complex generic drug products, when finalized, describe the agency's current thinking and expectations on how to develop generic drug products to specific reference listed drugs and are intended to assist the generic pharmaceutical industry with identifying the most appropriate methodology and evidence needed to support a specific generic drug’s approval. The published PSGs are announced in the Federal Register and made available to the public on FDA’s website.
What information is provided on this web page?
For new PSGs for generic drug products under development, this web page provides information on the active ingredient(s), the route of administration and dosage form, the reference listed drug (RLD) application number, and the planned publication month/year. In addition to this information, the list of PSGs for generic products under revision also includes the planned revision categories and brief descriptions. This web page describes FDA’s plans for issuing new and revised PSGs for both complex and non-complex generic drug products.
What do the different planned revision categories mean?
For revised PSGs, the planned revision categories briefly describe the nature of the anticipated revisions. Planned revision categories are defined as the following:
- Critical revision: PSG revision includes additional bioequivalence (BE) study(ies) or evidence recommended that is necessary to establish BE and support FDA approval reflecting a change in the safety or effectiveness of the drug product. The critical revision has a potential impact on all ANDAs including the approved applications. Holders of approved applications are also expected to address the change in the safety or effectiveness of the drug product reflected in a critical revision to maintain its FDA approval.
- Major revision: PSG revision includes additional BE study(ies) or evidence recommended that is necessary to establish BE and support FDA approval. Major revisions are categorized as in vivo major revisions and in vitro major revisions. Under GDUFA III, applicants or prospective applicants may request PSG teleconference if they have already commenced an in vivo bioequivalence study (i.e., the study protocol has been signed by the study sponsor and/or the contract research organization) to obtain Agency feedback on the potential impact of the new or revised PSG on its development program. Pre-submission or post-submission PSG meetings may be requested following feedback received at the PSG teleconference. Refer to GDUFA III Enhancements to the Pre-ANDA Program for additional details.
- In vivo major revision: PSG revision includes additional in vivo bioequivalence study(ies) or evidence recommended to support FDA approval.
- In vitro major revision: PSG revision includes additional in vitro bioequivalence study(ies) or evidence recommended to support FDA approval.
- Minor revision: Any revision to a PSG that is not considered critical or major, including but not limited to when a PSG is to be revised to add an in vivo or in vitro BE option, to clarify recommended study design, to certain study(ies), to provide alternative (less burdensome) approaches to the currently recommended study(ies), to add information on newly approved strengths of the RLD, or to make other recommendations that would not generally result in additional recommended bioequivalence study(ies) or evidence by an ANDA applicant necessary to support FDA approval. Minor revisions include both in vivo and in vitro changes.
- Editorial revision: PSG revision includes non-substantive changes such as updating external references, correcting grammatical issues, and streamlining the format of existing recommendations.
FDA will also provide specific information on the planned revision when such information is available for public release.
What is a complex generic drug product?
As described in the GDUFA III Commitment Letter and Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes (MAPP 5240.10), a complex generic drug product generally means the following:
- A product with:
- a complex active ingredient(s) (e.g., peptides, polymeric compounds, complex mixtures of APIs, naturally sourced ingredients)
- a complex formulation (e.g., liposomes, colloids)
- a complex route of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels)
- a complex dosage form (e.g., transdermals, metered dose inhalers, extended release injectables)
- Complex drug-device combination products (e.g., auto injectors, metered dose inhalers); and
- Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.
How often does FDA update this web page?
This web page will be updated each time FDA issues a new quarterly PSG batch. Each update removes the published PSGs and adds any new PSG under development or revision. This advance notice will help generic drug companies to plan for their development of generic drug products.
New and Revised PSGs for Generic Drug Products
Below is the list of PSGs for both complex and non-complex generic drug products that FDA plans to issue and the list of PSGs that FDA plans to revise in the coming year. While this list reflects FDA’s effort to be transparent regarding current plans for developing PSGs for generic drug products, it should be noted that timing may be subject to change.
Planned New PSGs for Complex and Non-Complex
Generic Drug Products
Updated May 16, 2024
Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Product Complexity | Planned Publication | Updates |
---|---|---|---|---|---|---|
Acalabrutinib Maleate | Oral | Tablet | 216387 | Non-Complex | 11/2024 | Newly added |
Adapalene; Benzoyl Peroxide; Clindamycin Phosphate | Topical | Gel | 216632 | Complex | 11/2024 | Newly added |
Air Polymer-Type A | Intrauterine | Foam | 212279 | Complex | 08/2024 | No change |
Albuterol Sulfate; Budesonide | Inhalation | Aerosol, Metered | 214070 | Complex | 02/2025 | Newly added |
Amikacin Sulfate | Inhalation | Suspension, Liposomal | 207356 | Complex | 08/2024 | Planned publication date change to a later date |
Aripiprazole | Intramuscular | Suspension, Extended Release | 217006 | Complex | 11/2024 | Newly added |
Aripiprazole | Oral | Tablet | 207202 | Complex | Within the next 12 months | No change |
Aripiprazole Lauroxil | Intramuscular | Suspension, Extended Release | 209830 | Complex | 11/2024 | Newly added |
Budesonide; Formoterol Fumarate | Inhalation | Aerosol, Metered | 216579 | Complex | 02/2025 | Newly added |
Buspirone Hydrochloride | Oral | Capsule | 021190 | Non-Complex | 11/2024 | Newly added |
Cantharidin | Topical | Solution | 212905 | Non-Complex | 11/2024 | Newly added |
Capivasertib | Oral | Tablet | 218197 | Non-Complex | 05/2025 | Newly added |
Cefazolin Sodium | Intravenous | Powder | 211413 | Non-Complex | 11/2024 | Newly added |
Cephalexin | Oral | Tablet | 063024 | Non-Complex | 11/2024 | Newly added |
Clobetasol Propionate | Topical | Cream | 209483 | Complex | Beyond 12 months | No change |
Cyclosporine | Ophthalmic | Solution | 217469 | Non-Complex | 11/2024 | Newly added |
Desmopressin Acetate | Nasal | Spray, Metered | 201656 | Complex | 11/2024 | No change |
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | Ophthalmic | Ointment | 050065 | Complex | 11/2024 | Newly added |
Eplontersen Sodium | Subcutaneous | Solution | 217388 | Complex | 11/2024 | Newly added |
Etrasimod Arginine | Oral | Tablet | 216956 | Non-Complex | 02/2025 | Newly added |
Fezolinetant | Oral | Tablet | 216578 | Non-Complex | 08/2024 | No change |
Fluticasone Propionate | Nasal | Spray, Metered | 209022 | Complex | Beyond 12 months | No change |
Fruquintinib | Oral | Capsule | 217564 | Non-Complex | 05/2025 | Newly added |
Gepirone Hydrochloride | Oral | Tablet, Extended Release | 021164 | Non-Complex | Beyond 12 months | Planned publication date change to a later date |
Heparin Sodium; Taurolidine | N/A | Solution | 214520 | Complex | 08/2024 | Newly added |
Icatibant Acetate | Subcutaneous | Injectable | 022150 | Non-Complex | 11/2024 | Newly added |
Lanreotide Acetate | Subcutaneous | Solution | 215395 | Complex | Within the next 12 months | No change |
Leniolisib Phosphate | Oral | Tablet | 217759 | Non-Complex | 08/2024 | No change |
Levonorgestrel | Intrauterine | Intrauterine Device | 208224 | Complex | 08/2024 | Planned publication date assigned |
Lidocaine; Tetracaine | Topical | Patch | 021623 | Complex | Beyond 12 months | No change |
Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate | Oral | For Solution | 215344 | Complex | 11/2024 | No change |
Mitomycin | Pyelocalyceal | Powder | 211728 | Complex | 11/2024 | Planned publication date assigned |
Momelotinib Dihydrochloride | Oral | Tablet | 216873 | Non-Complex | 02/2025 | Newly added |
Mometasone Furoate | Implantation | Implant | 209310 | Complex | 02/2025 | No change |
Naloxone Hydrochloride | Nasal | Spray, Metered | 217722 | Complex | 08/2024 | No change |
Nedosiran Sodium | Injection | Solution | 215842 | Complex | 08/2024 | Newly added |
Nirmatrelvir; Ritonavir | Oral | Tablet | 217188 | Non-Complex | 08/2024 | No change |
Nirogacestat Hydrobromide | Oral | Tablet | 217677 | Non-Complex | 05/2025 | Newly added |
Paclitaxel | Intravenous | Powder | 216338 | Complex | 11/2024 | Newly added |
Palovarotene | Oral | Capsule | 215559 | Non-Complex | 11/2024 | No change |
Patiromer Sorbitex Calcium | Oral | Powder | 205739 | Complex | Within the next 12 months | No change |
Pegcetacoplan | Intravitreal | Solution | 217171 | Complex | 08/2024 | Newly added |
Pemetrexed Disodium | Intravenous | Solution | 215179 | Non-Complex | 11/2024 | Newly added |
Phentolamine Mesylate | Ophthalmic | Solution | 217064 | Non-Complex | 11/2024 | Newly added |
Quizartinib Dihydrochloride | Oral | Tablet | 216993 | Non-Complex | 11/2024 | No change |
Repotrectinib | Oral | Capsule | 218213 | Non-Complex | 05/2025 | Newly added |
Risperidone | Intramuscular | For Suspension, Extended Release | 212849 | Complex | 08/2024 | Newly added |
Risperidone | Subcutaneous | Suspension, Extended Release | 213586 | Complex | 11/2024 | Newly added |
Ritlecitinib Tosylate | Oral | Capsule | 215830 | Non-Complex | 11/2024 | No change |
Roflumilast | Topical | Cream | 215985 | Complex | Within the next 12 months | No change |
Sotagliflozin | Oral | Tablet | 216203 | Non-Complex | 08/2024 | No change |
Tafluprost | Ophthalmic | Solution/Drops | 202514 | Non-Complex | 08/2024 | Newly added |
Teriparatide | Subcutaneous | Solution | 021318 | Complex | 08/2024 | Newly added |
Tofersen | Intrathecal | Solution | 215887 | Complex | 08/2024 | No change |
Treprostinil | Inhalation | Powder | 214324 | Complex | 11/2024 | No change |
Trofinetide | Oral | Solution | 217026 | Non-Complex | 08/2024 | No change |
Vamorolone | Oral | Suspension | 215239 | Non-Complex | 02/2025 | Newly added |
Zuranolone | Oral | Capsule | 217369 | Non-Complex | 02/2025 | Newly added |
Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated May 16, 2024
Active Ingredient(s) | Route Of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Updates |
---|---|---|---|---|---|---|---|
Acetaminophen; Butalbital | Oral | Capsule | 088831 | Minor Revision: Remove recommendation on a strength due to safety concerns | Non-Complex | Within the next 12 months | No change |
Albuterol Sulfate | Inhalation | Aerosol, Metered | 020503, 020983, 021457 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons |
Complex | 08/2024 | No change |
Albuterol Sulfate; Ipratropium Bromide | Inhalation | Spray, Metered | 021747 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons |
Complex | 08/2024 | No change |
Allopurinol | Oral | Tablet | 016084 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 11/2024 | Planned publication date change to a later date |
Apalutamide | Oral | Tablet | 210951 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) | Non-Complex | 08/2024 | No change |
Azelaic Acid | Topical | Cream | 020428 | Minor Revision: Add an in vitro BE option | Complex | 08/2024 | No change |
Azelaic Acid | Topical | Gel | 021470 | Minor Revision: Add an in vitro BE option | Complex | 08/2024 | No change |
Bempedoic Acid; Ezetimibe | Oral | Tablet | 211617 | Minor Revision: Change in study design for in vivo BE studies | Non-Complex | 08/2024 | Newly added |
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | Oral | Tablet | 210251 | Minor Revision: Add information on newly approved strength of the RLD (lower strength) | Non-Complex | 11/2024 | Newly added |
Budesonide | Inhalation | Powder, Metered | 021949 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Newly added |
Budesonide; Formoterol Fumarate Dihydrate | Inhalation | Aerosol, Metered | 021929 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 02/2025 | No change |
Bupropion Hydrochloride | Oral | Tablet, Extended Release | 020358, 020711 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Carvedilol Phosphate | Oral | Capsule, Extended Release | 022012 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Ciprofloxacin; Dexamethasone | Otic | Suspension/Drops | 021537 | Minor Revision: Remove recommendations on in vitro microbial kill rate study; Clarify in vitro study design; Add recommendations for device comparisons | Complex | 08/2024 | Planned publication date change to a later date |
Ciprofloxacin Hydrochloride; Hydrocortisone | Otic | Suspension/Drops | 020805 | Minor Revision: Remove recommendations on in vitro microbial kill rate study; Clarify in vitro study design; Add recommendations for device comparisons | Complex | 08/2024 | Planned publication date change to a later date |
Cladribine | Oral | Tablet | 022561 | Minor Revision: Add an in vitro BE option | Non-Complex | 08/2024 | Newly added |
Dalfampridine | Oral | Tablet, Extended Release | 022250 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Dapagliflozin; Metformin Hydrochloride | Oral | Tablet, Extended Release | 205649 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Donepezil Hydrochloride; Memantine Hydrochloride | Oral | Capsule, Extended Release | 206439 | Editorial Revision: Update the language Minor Revision: Remove recommendations on alcohol dose dumping |
Non-Complex | 08/2024 | Newly added |
Fentanyl Citrate | Nasal | Spray, Metered | 022569 | Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the language Minor Revision: Clarify in vitro and in vivo study design; Add recommendations for device comparisons |
Complex | 08/2024 | No change |
Ferric Carboxymaltose | Intravenous | Solution | 203565 | Minor Revision: Add an in vivo BE study option | Complex | 11/2024 | Newly added |
Ferric Citrate | Oral | Tablet | 205874 | Minor Revision: Change in study design for in vivo BE study(ies) with revised BE criteria | Complex | 08/2024 | Planned publication date change to a later date |
Ferumoxytol | Intravenous | Solution | 022180 | Minor Revision: Add an in vivo BE option | Complex | 11/2024 | Newly added |
Fluorouracil | Topical | Cream | 020985 | Minor Revision: Add an in vitro BE option | Complex | Beyond 12 months | No change |
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 209482 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Newly added |
Fluticasone Propionate | Inhalation | Aerosol, Metered | 021433 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2024 | No change |
Fluticasone Propionate | Inhalation | Powder | 020833 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Planned publication date change to a earlier date; Revision description change |
Fluticasone Propionate | Inhalation | Powder | 208798 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Newly added |
Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Aerosol, Metered | 021254 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2024 | No change |
Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 021077 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Planned publication date change to a earlier date; Revision description change |
Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 208799 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Newly added |
Formoterol Fumarate | Inhalation | Powder | 020831 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | No change |
Formoterol Fumarate; Mometasone Furoate | Inhalation | Aerosol, Metered | 022518 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 02/2025 | No change |
Halobetasol Propionate | Topical | Ointment | 019968 | Editorial Revision: Update the language Minor Revision: Add an in vitro BE option |
Complex | 08/2024 | No change |
Hydrochlorothiazide; Metoprolol Succinate | Oral | Tablet, Extended Release | 021956 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Hydromorphone Hydrochloride | Oral | Tablet, Extended Release | 021217 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Ibrutinib | Oral | Tablet | 210563 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS | Non-Complex | 08/2024 | No change |
Labetalol Hydrochloride | Oral | Tablet | 018687, 018716 | Minor Revision: Expand the eligibility for an in vitro-based BE option | Non-Complex | 11/2024 | Newly added |
Lanreotide Acetate | Subcutaneous | Solution | 022074 | Editorial Revision: Update the language Minor Revision: Add recommendations for device comparisons |
Complex | Within the next 12 months | No change |
Levalbuterol Tartrate | Inhalation | Aerosol, Metered | 021730 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 08/2024 | No change |
Levomilnacipran Hydrochloride | Oral | Capsule, Extended Release | 204168 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Levonorgestrel | Intrauterine | Intrauterine Device | 203159 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 08/2024 | Planned publication date assigned |
Memantine Hydrochloride | Oral | Capsule, Extended Release | 022525 | Editorial Revision: Update the language Minor Revision: Remove recommendations on alcohol dose dumping |
Non-Complex | 08/2024 | Newly added |
Metformin Hydrochloride; Saxagliptin Hydrochloride | Oral | Tablet, Extended Release | 200678 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Metformin Hydrochloride; Sitagliptin Phosphate | Oral | Tablet, Extended Release | 202270 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Mometasone Furoate | Inhalation | Aerosol, Metered | 205641 | Minor Revision: Add an in vitro and an in vivo BE option | Complex | 02/2025 | No change |
Mometasone Furoate | Inhalation | Powder | 021067 | Minor Revision: Clarify in vivo study design | Complex | 08/2024 | Newly added |
Morphine Sulfate | Oral | Capsule, Extended Release | 020616 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Morphine Sulfate | Oral | Capsule, Extended Release | 079040 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Morphine Sulfate | Oral | Tablet, Extended Release | 019516 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Naloxone Hydrochloride | Nasal | Spray, Metered | 208411 | Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the language Minor Revision: Clarify in vitro and in vivo study design; Revise recommendations for device comparisons |
Complex | 08/2024 | No change |
Nepafenac | Ophthalmic | Suspension/Drops | 021862 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 08/2024 | Planned publication date change to a later date; Revision description change |
Nepafenac | Ophthalmic | Suspension/Drops | 203491 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 08/2024 | Planned publication date change to a later date; Revision description change |
Olaparib | Oral | Tablet | 208558 | Minor Revision: Clarify in vivo study design | Non-Complex | 11/2024 | Newly added |
Olodaterol Hydrochloride | Inhalation | Spray, Metered | 203108 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons |
Complex | 08/2024 | No change |
Olodaterol Hydrochloride; Tiotropium Bromide | Inhalation | Spray, Metered | 206756 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons |
Complex | 08/2024 | No change |
Oxcarbazepine | Oral | Tablet, Extended Release | 202810 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Oxymorphone Hydrochloride | Oral | Tablet, Extended Release | 021610 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Phentermine Hydrochloride; Topiramate | Oral | Capsule, Extended Release | 022580 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Posaconazole | Oral | Tablet, Delayed Release | 205053 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs; Change in vivo study design |
Non-Complex | 08/2024 | Newly added |
Pramipexole Dihydrochloride | Oral | Tablet, Extended Release | 022421 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Add information on newly approved (lower or middle) strengths of the RLD/RS |
Non-Complex | 08/2024 | Newly added |
Progesterone | Vaginal | Insert | 022057 | Editorial Revision: Update the language Minor Revision: Add additional in vivo study design; Add recommendations for device comparisons; Change in study design for in vivo BE studies |
Complex | 08/2024 | No change |
Promethazine Hydrochloride | Rectal | Suppository | 010926 | Editorial Revision: Update the language | Complex | 08/2024 | No change |
Quetiapine Fumarate | Oral | Tablet, Extended Release | 022047 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Salmeterol Xinafoate | Inhalation | Powder | 020692 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | No change |
Tacrolimus | Oral | Tablet, Extended Release | 206406 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Tapentadol Hydrochloride | Oral | Tablet, Extended Release | 200533 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Tiotropium Bromide | Inhalation | Powder | 021395 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | No change |
Tiotropium Bromide | Inhalation | Spray, Metered | 021936 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons |
Complex | 08/2024 | No change |
Tramadol Hydrochloride | Oral | Tablet | 020281 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) | Non-Complex | 11/2024 | Planned publication date change to a later date |
Tramadol Hydrochloride | Oral | Tablet, Extended Release | 021692 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design |
Non-Complex | 08/2024 | Newly added |
Trospium Chloride | Oral | Capsule, Extended Release | 022103 | Editorial Revision: Update the language Minor Revision: Clarify in vitro and in vivo study designs |
Non-Complex | 08/2024 | Newly added |
Venlafaxine Hydrochloride | Oral | Tablet, Extended Release | 022104 | Editorial Revision: Update the language Minor Revision: Clarify in vitro study design; Change in study design for in vivo BE studies |
Non-Complex | 08/2024 | Newly added |
Verteporfin | Injection | Injectable | 021119 | Editorial Revision: Update the language | Complex | 08/2024 | Newly added |