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- Drug Firm Annual Registration Status
- Drug Firm Annual Registration Status Download File
- National Drug Code Directory
- NDC Unfinished Drugs Excluded Database File
- NDC Database Excluded Packages and Products
- Wholesale Distributor and Third-Party Logistics Providers Reporting
May 17, 2024
- FDA Drug Shortages
- Amoxicillin Powder, For Suspension (Updated - Currently in Shortage)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Azacitidine Injection (Updated - Currently in Shortage)
- Azithromycin for Suspension (New - Discontinuation)
- Bumetanide Injection (Updated - Currently in Shortage)
- Cefotaxime Sodium Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Enalaprilat Injection (Updated - Currently in Shortage)
- Erythromycin Ointment (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Solution (Updated - Currently in Shortage)
- Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Tablet (Updated - Currently in Shortage)
- Midazolam Hydrochloride Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Neomycin Sulfate Tablet (Updated - Resolved)
- Promethazine Hydrochloride Injection (Updated - Currently in Shortage)
- Remifentanil Hydrochloride Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Sterile Water Injection (Updated - Currently in Shortage)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)
- Valproate Sodium Injection (Updated - Currently in Shortage)
- CDER Center for Clinical Trial Innovation: C3TI Compass (Knowledge Repository)
- Public Workshop: Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
- Webinar: Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule
May 16, 2024
May 15, 2024
- FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Dextrose Monohydrate Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate Capsule (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Injection, Syringes (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Heparin Sodium Injection (Updated - Currently in Shortage)
- Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
- Midazolam Hydrochloride Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Penicillin G Benzathine Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Quinapril Hydrochloride Tablet (Updated - Currently in Shortage)
- Quinapril/Hydrochlorothiazide Tablet (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sterile Water Injection (Updated - Currently in Shortage)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablet (Updated - Currently in Shortage)
- Vecuronium Bromide Injection (Updated - Currently in Shortage)
May 14, 2024
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Cefotetan Disodium Injection (New - Currently in Shortage)
- Mefloquine Hydrochloride Tablet (New - Currently in Shortage)
May 13, 2024
- FDA Drug Shortages
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Flurazepam Hydrochloride Capsule (Updated - Currently in Shortage)
- Heparin Sodium Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablet (Updated - Currently in Shortage)
May 10, 2024
- Drug Trials Snapshots: OGSIVEO
- Activities Report of the Generic Drug Program (Updated)
- Competitive Generic Therapy Approvals (Updated)
- Orange Book
- Approved Drug Products with Therapeutic Equivalence Evaluations
- Orange Book Current Cumulative Supplement (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (updated)
- Orange Book Patent Listing Dispute List (updated)
May 9, 2024
- Drug Trials Snapshots: FRUZAQLA
- Drug Trials Snapshots: RYSTIGGO
- FDA Drug Shortages
- Iloprost Solution (New - Discontinuation)
May 8, 2024
- Drug Trials Snapshots: ZELSUVMI
- Drug Trials Snapshots: TEVIMBRA
- FDA Drug Shortages
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Updated - Currently in Shortage)
- Cefotetan Disodium Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Dextrose Monohydrate Injection (Updated - Currently in Shortage)
- Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Fentanyl Citrate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Heparin Sodium Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Midazolam Hydrochloride Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Remifentanil Hydrochloride Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Updated - Currently in Shortage)
- Sterile Water Injection (Updated - Currently in Shortage)
May 7, 2024
- Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest
- Drugs@FDA Data Files (Updated)
- Drug Trials Snapshots: JOENJA
- Drug Trials Snapshots: ZURZUVAE
- FDA Drug Shortages
- Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Resolved)
May 6, 2024
- Draft Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
- FDA Drug Shortages
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Azacitidine Injection (Updated - Currently in Shortage)
- Capecitabine Tablet (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clonazepam Tablet (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Fentanyl Citrate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Heparin Sodium Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Tablet (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Naltrexone Hydrochloride Tablet (Updated - Currently in Shortage)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)
- Generic Drugs Program Monthly and Quarterly Activities Report (Updated)
- Drug Trials Snapshot: FILSPARI
- Drug Trials Snapshot: AUGTYRO
May 2, 2024
- Counterfeit Version of Botox Found in Multiple States (Updated)
- CDER Quantitative Medicine Center of Excellence (QM CoE) (New)
- Meeting: Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials
April 30, 2024
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Albuterol Sulfate Powder, Metered (New - Discontinuation)
- Clomipramine Hydrochloride Capsule (New - Discontinuation)
- Doxycycline Hyclate Tablet (New - Discontinuation)
- Fesoterodine Fumarate Tablet, Extended Release (New - Discontinuation)
- Fluticasone Propionate Powder, Metered (New - Discontinuation)
- Fluticasone Propionate; Salmeterol Xinafoate Powder, Metered (New - Discontinuation)
- Temazepam Capsule (New - Discontinuation)
April 29, 2024
- FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
- FDA alerts health care professionals of pregnancy problems associated with thiopurines
- FDA approves first drug for WHIM syndrome, a rare disorder that can lead to recurrent, life-threatening infections
- FDA Drug Shortages
- Cinacalcet Hydrochloride Tablet (New - Discontinuation)
- Semaglutide Injection (Updated - Currently in Shortage)
April 26, 2024
- Competitive Generic Therapy Approvals (Updated)
- Patent Certifications and Suitability Petitions (Updated)
- FDA Drug Shortages
- Amoxapine Tablet (Updated - Currently in Shortage)
- Amoxicillin Powder, For Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
- Azacitidine Injection (Updated - Currently in Shortage)
- Capecitabine Tablet (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clonazepam Tablet (Updated - Currently in Shortage)
- Disopyramide Phosphate Capsule (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Isoniazid Tablet (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Tablet (Updated - Currently in Shortage)
- Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
- Streptozocin Powder, For Solution (Updated - Currently in Shortage)
- Sucralfate Tablet (Updated - Currently in Shortage)
- Sulfasalazine Tablet (Updated - Currently in Shortage)
- Impact Story: How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces
- Draft Guidance: Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
April 25, 2024
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Capecitabine Tablet (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Tablet (Updated - Currently in Shortage)
- Vecuronium Bromide Injection (Updated - Currently in Shortage)
- Impact Story: Peptides, proteins, and the risks of cardiac arrythmias: A CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids
April 24, 2024
- FDA Drug Shortages
- Azacitidine Injection (Updated - Currently in Shortage)
- Guidance for Industry: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
April 23, 2024
- Drugs@FDA Data Files (Updated)
- FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma
- FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS
- FDA Drug Shortages
- Dextrose Monohydrate Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Nitroglycerin Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Irrigation (Updated - Currently in Shortage)
- Sterile Water Irrigant (Updated - Currently in Shortage)
- OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites
April 22, 2024
- FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
- 2024 Compounding Quality Center of Excellence Annual Conference
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
April 19, 2024
- FDA Drug Shortages
- Diazepam Gel (Updated - Resolved)
April 18, 2024
- CDER Conversation: Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information
- FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
April 17, 2024
- Public Notification: Ossos-Sans contains hidden drug ingredients
- FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy
- FDA Drug Shortages
- Fludarabine Phosphate Injection (Updated - Resolved)
- Ketamine Hydrochloride Injection (New - Currently in Shortage)
- Tirzepatide Injection (Updated - Currently in Shortage)
April 16, 2024
- Drugs@FDA Data Files (Updated)
- Drug Trials Snapshots: VANFLYTA
- FDA Drug Shortages
- Amifostine Injection (Updated - Discontinuation)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clonazepam Tablet (Updated - Currently in Shortage)
- Collagenase Clostridium Histolyticum Ointment (Updated - Currently in Shortage)
- Cromolyn Sodium Concentrate (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Digoxin Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate Capsule (Updated - Currently in Shortage)
- Enalaprilat Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Promethazine Hydrochloride Injection (Updated - Currently in Shortage)
- Riluzole Oral Suspension (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Updated - Currently in Shortage)
- Valproate Sodium Injection (Updated - Currently in Shortage)
- Vecuronium Bromide Injection (Updated - Currently in Shortage)
- Vinblastine Sulfate Injection (Updated - Currently in Shortage)