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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 6, 2023
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)
June 16, 2023
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Tirzepatide Injection (Updated - Currently in Shortage)
June 15, 2023
- Drug Trials Snapshots: KIMMTRAK
- FDA Drug Shortages
- Atropine Sulfate Injection (New - Currently in Shortage)
June 14, 2023
- FDA Drug Shortages
- Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (Updated - Currently in Shortage)
- Oxybutynin Chloride Gel (New - Discontinuation)
June 13, 2023
- Drugs@FDA Data Files (updated)
- Online Opioid Summits (updated)
- Competitive Generic Therapy Approvals (updated)
- Drug Trials Snapshots: MOUNJARO
- FDA 更新警告以提高用於治療多動症 (ADHD) 和其他疾病的處方興奮劑的安全使用 (Chinese language version of "FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions")
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- 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)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dextrose 25% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (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)
- Furosemide 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)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate 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)
- Potassium Chloride Concentrate 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)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated)
June 12, 2023
June 9, 2023
- FDA Drug Shortages
- Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
- Orange Book
June 8, 2023
- FDA Drug Shortages
- Amino Acids (Updated - Currently in Shortage)
- Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment (Updated - Discontinuation)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Cyclopentolate Ophthalmic Solution (Updated - Currently in Shortage)
- Desmopressin Acetate Nasal Spray (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Oxytocin Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
June 7, 2023
- Drug Trials Snapshot: CIBINQO
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
June 6, 2023
- Drugs@FDA Data Files (updated)
- For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems
- Draft Guidance: E6(R3) GOOD CLINICAL PRACTICE (GCP)
- FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Amoxicillin Oral Powder for Suspension (New - Currently in Shortage)
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Isoniazid Tablets (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Montelukast Sodium Oral Granules (New - Discontinuation)
- Sulfasalazine Tablets (Updated - Currently in Shortage)