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Updated Monday through Friday
- CDER Launches New Accelerating Rare disease Cures (ARC) Program
- 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
July 17, 2023
- FDA Drug Shortages
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Novel Drug Approvals for 2023 (updated)
July 14, 2023
- FDA Drug Shortages
- Lisdexamfetamine Dimesylate Capsules (New - Currently in Shortage)
- Orange Book
- 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)
- Appendix A: Product Name Index (updated)
- Appendix B: Product Name Sorted by Applicant (updated)
- Appendix C: Uniform Terms (updated)
July 13, 2023
- FDA Drug Shortages
- Edetate Calcium Disodium Injection (New - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
July 12, 2023
- FDA Drug Shortages
- Diazepam Rectal Gel (Updated - Currently in Shortage)
- Flurazepam Hydrochloride Capsules (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (New - Currently in Shortage)
- Rivaroxaban Oral Suspension (Updated - Resolved)
July 11, 2023
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Cisplatin Injection (Updated - Currently in Shortage)
- Memantine Hydrochloride Extended Release Capsules (New - Discontinuation)
- Memantine Hydrochloride Tablets (New - Discontinuation)
- Sincalide (Kinevac) Lyophilized Powder for Injection (Updated - Resolved)
- SBIA Chronicles: Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
- Draft Guidance: Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
- Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma (updated)
July 10, 2023
- Drug Trials Snapshot: TAVNEOS
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 25% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Penicillin G Benzathine Injectable Suspension (Updated - Currently in Shortage)
- Potassium Acetate Injection (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 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- List of Determinations Including Written Request (updated)
July 6, 2023
- Drug Trials Snapshot: FOTIVDA
- Electronic Registration and Listing Compliance Program
- FDA Drug Shortages
- Alprostadil (Muse) Suppository (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
July 5, 2023
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
July 3, 2023
- FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients
- Generic Drugs Program Monthly and Quarterly Activities Report (updated)
June 30, 2023
- Drug Trials Snapshots: BREXAFEMME
- FDA Drug Shortages
- Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
- Patent Certifications and Suitability Petitions (updated)
June 29, 2023
- FDA Drug Shortages
- 0.9% Sodium Chloride Irrigation (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (New - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sterile Water for Irrigation (Updated - Currently in Shortage)
- Final Guidance: Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
- Competitive Generic Therapy Approvals (updated)
June 28, 2023
- Drug Trials Snapshots: TRUSELTIQ
- FDA Drug Shortages
- Exemestane Tablets (New - Discontinuation)
- Minocycline Hydrochloride Extended Release Tablets (New - Discontinuation)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
June 27, 2023
- Drugs@FDA Data Files (updated)
- Draft Guidance: Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Final Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
June 26, 2023
- From Our Perspective: CDER’s Efforts to Expand Opioid Disposal Options
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Chloramphenicol Sodium Succinate Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
June 23, 2023
- Draft Guidance: Psychedelic Drugs: Considerations for Clinical Investigations
- FDA Drug Shortages
- Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
- Interferon Beta-1b Injection (New - Discontinuation)
June 22, 2023
- Draft Guidance: Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act
- Drug Trials Snapshots: PYLARIFY
June 21, 2023
June 20, 2023
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Capecitabine Tablets (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clonazepam Tablets (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Digoxin Injection (Updated - Currently in Shortage)
- Fluconazole Tablets (New - Discontinuation)
- Glimeperide Tablets (New - Discontinuation)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Isoniazid Tablets (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sucralfate Tablets (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)