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Updated Monday through Friday

• 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 

August 12, 2020

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Chlorothiazide (Diuril) Oral Suspension (New - Currently in Shortage)
  • Cisatracurium Besylate 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)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection, USP (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Tablets, USP (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lorazepam Injection, USP (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Sertraline Hydrochloride Oral Solution, USP (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

August 11, 2020

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Misoprostol Tablets (New - Discontinuation)
  • Nadolol Tablets (New - Discontinuation)
  • Olopatadine Hydrochloride Ophthalmic Solution (New - Discontinuation)
  • Theophylline Extended Release Tablets and Capsules (New - Discontinuation)

August 10, 2020

• Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
• Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

August 7. 2020

• Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry
• The FDA/DIA Complex Generic Drug-Device Combination Products Conference 2020

August 6, 2020

• Drug Trial Snapshot: XEGLYZE (New)
• FY 2019 Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments (New)
• Ferring US Issues Voluntary Nationwide Recall of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE Nasal Spray 1.5 mg/mL Due to Superpotency
• FDA Drug Shortages
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)

August 5, 2020

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
• Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry

August 4, 2020

• Drug Shortages Response | COVID-19 (update)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Heparin Sodium and Sodium Chloride 0.9% Injection (New - Currently in Shortage)
  • Pantoprazole Sodium for Injection (New - Currently in Shortage)
• FDA updates on hand sanitizers consumers should not use (update)
• Information for Health Care Facilities and Providers on “in-use time” | COVID-19 (New)

August 3, 2020

• FDA Drug Shortages
  • Midazolam Injection, USP (Updated - Currently in Shortage
• Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry

July 31, 2020

• FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma (New)
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection, USP (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Tablets, USP (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Hydroxyzine Pamoate Oral Capsules (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Sertraline Hydrochloride Oral Solution, USP (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)

July 30, 2020

• FDA Drug Shortages
  • Cefepime Injection (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Mesalamine (CANASA®) Suppositories (New - Discontinuation)

July 29, 2020

• A Pharmaceutical Quality Webinar for Global Stakeholders
• FDA Drug Safety Podcast: FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
• Guidance for Industry:
  • Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
  • Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval
• Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance (updated)

July 28, 2020

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Montelukast Sodium Chewable Tablet (New - Discontinuation)
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry

July 27, 2020

• FDA Drug Shortages
  • Adalimumab (Humira) Pre-filled Syringe (New - Discontinuation)

July 24, 2020

• Drug Trials Snapshots: INQOVI
• FDA Drug Shortages
  • Cefepime Injection (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection (New - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
• Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

July 23, 2020

• FDA Drug Shortages
  • Caspofungin Acetate Injection (New - Discontinuation)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
• FDA Drug Safety Communication: FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
• Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA (updated)

July 22, 2020

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Atropine Sulfate Ophthalmic Ointment (Updated - Currently in Shortage)
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Cefotaxime Sodium Injection (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Diphenhydramine Injection (Updated - Currently in Shortage)
  • Enalaprilat Injection, USP (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Famotidine Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lorazepam Injection, USP (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Promethazine (Phenergan) Injection (Updated - Currently in Shortage)

July 21, 2020

• Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
• Drug Trials Snapshots: BYFAVO
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cisatracurium Besylate Injection (Updated - Currently in Shortage)

July 20, 2020

• CDER Patient-Focused Drug Development
• CDER Conversations
  • Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process
  • New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program
• FDA Drug Shortages
  • Deferasirox Tablets (New - Discontinuation)
  • Ketamine Injection (Updated - Currently in Shortage)

July 17, 2020

• CDER Warning Letters 2020 (updated)

July 16, 2020

• Manual of Policies and Procedures (MAPP) MAPP 4651.4 Rev.1  CDER Incentive Awards Program (Cash and Time-off)
• CDER Small Business & Industry Assistance (updated)
• FDA Drug Shortages
  • Amantadine Hydrochloride Capsules (New - Discontinuation)
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Azithromycin Tablets (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (New - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
• La FDA advierte a los consumidores sobre los riesgos de contaminación por metanol en algunos desinfectantes para las manos (updated)

July 15, 2020

• Drug Trials Snapshots: DOJOLVI
• FDA Drug Shortages
  • Azithromycin Tablets (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Furosemide Injection, USP (Updated - Currently in Shortage)
  • Hydrocortisone Tablets, USP (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Midazolam Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Sertraline Hydrochloride Oral Solution, USP (Updated - Currently in Shortage)
  • Sertraline Hydrochloride Tablets (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)

July 14, 2020

• Drugs@FDA Data Files (updated)
• Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)
• Test your knowledge about hand sanitizer. Take our hand sanitizer quiz.
• Patent Certifications and Suitability Petitions (updated)
• Drug Trials Snapshots: RUKOBIA
• FDA Drug Shortages
  • Tacrolimus Capsules (Updated - Currently in Shortage)
• First Generic Drug Approvals (updated)