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December 10, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Alogliptin Tablets (Updated - Currently in Shortage)
  • Erythromycin Ophthalmic Ointment (Updated - Currently in Shortage)
  • Leuprolide Acetate (Lupron Depot; Lupron Depot Ped) Injection (New - Currently in Shortage)
  • Methocarbamol Tablets (Updated - Currently in Shortage)
  • Potassium Acetate Injection, USP (Updated - Currently in Shortage)
  • Primaquine Phosphate Tablet, EQ 15mg Base (Updated - Resolved)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

December 9, 2019

• Drug Trials Snapshots ADAKVEO
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Leuprolide Acetate (Lupron Depot; Lupron Depot Ped) Injection (New - Discontinuation)   
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Oxytocin Injection, USP Synthetic (Updated - Currently in Shortage)
  • Risedronate Tablets (New - Discontinuation)   
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Vinblastine Sulfate Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

December 6, 2019

• Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Aminophylline Injection, USP (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Budesonide Extended Release Tablets (New - Discontinuation)    
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Dextrose 25% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (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)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (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)
  • Ketorolac Tromethamine 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)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Metronidazole Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection, USP (Updated - Currently in Shortage)
  • Procainamide Hydrochloride Injection, USP (Currently in Shortage)
  • Sodium Acetate Injection, USP (Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

December 5, 2019

• CURE ID App Lets Clinicians Report Novel Uses of Existing Drugs
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Hydroxyzine Pamoate Oral Capsules (New - Currently in Shortage)
  • Methylprednisolone Tablets (New - Discontinuation)
  • Sumatriptan Succinate Injection (New - Discontinuation)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

December 4, 2019

• FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) (updated)
• Public Notification: Detox Plus contains hidden drug ingredients
• Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage) 
  • Tranexamic Acid Tablets (New - Discontinuation)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

December 3, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: XCOPRI
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Levetiracetam Extended-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Vincristine Sulfate Injection, USP (Preservative-Free) (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

December 2, 2019

• Influenza (Flu) Antiviral Drugs and Related Information (updated)
• Drug Trials Snapshot: FETROJA
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Letermovir (Prevymis) Injection (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)

November 29, 2019

• Drug Trials Snapshots: BRUKINSA
• Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 27, 2019

• FDA Drug Shortages
  • Levetiracetam Extended-Release Oral Tablets, USP (Updated - Currently in Shortage)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 26, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
  • Thioridazine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Thiothixene Capsules (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

ovember 25, 2019

• FDA Drug Shortages
  • Hydrocortisone Acetate Suppository (New - Discontinuation)
  • Hydrocortisone Acetate Suppository (New - Discontinuation)
  • Ketoprofen Capsules (New - Discontinuation)
  • Ketoprofen Capsules (Updated - Currently in Shortage)
  • Loxapine Capsules (New - Currently in Shortage)
  • Loxapine Capsules (New - Discontinuation)
  • Metoprolol Tartrate Injection, USP (Updated - Currently in Shortage)
  • Phenobarbital Oral Solution (New - Discontinuation)
• Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products Guidance for Industry
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 22, 2019

• Drug Trials Snapshots: REBLOZYL
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Clozapine (FazaClo® ) Orally Disintegrating Tablets (New - Discontinuation)
  • Dextrose 25% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Paclitaxel Injection, USP (New - Discontinuation)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
• Drug Trials Snapshots: GIVLAARI
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 21, 2019

• Division of Pediatric and Maternal Health - FDA Public Meetings 
• Division of Pediatric and Maternal Health - Selected Presentations 
• Division of Pediatric and Maternal Health - Publications 
• Division of Pediatric and Maternal Health - Pediatric Guidances 
• Division of Pediatric and Maternal Health - Maternal Health Guidance(s) 
• Division of Pediatric and Maternal Health - Lactation Studies 
• Division of Pediatric and Maternal Health - Post-Approval Studies in Pregnant Women 
• Division of Pediatric and Maternal Health - Clinical Trials in Pregnant Women 
• Division of Pediatric and Maternal Health - Pediatric Summaries, Full Reviews, Statistics & Pediatric Exclusivity Determinations 
• Division of Pediatric and Maternal Health - Pediatrics
• Division of Pediatric and Maternal Health - Maternal Health
• Drug Trials Snapshots: EXEM FOAM
• FDA Drug Shortages
  • Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Tizanidine Hydrochloride Tablets (New - Discontinuation)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 20, 2019

• Antibacterial Susceptibility Test Interpretive Criteria: Cefiderocol Injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Disulfiram Tablets (Updated - Currently in Shortage)
  • Haloperidol Tablets (Updated - Resolved)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry

November 19, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 18, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Eptifibatide (Integrilin) Injection (New - Discontinuation)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

November 15, 2019

• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated -Currently in Shortage)
  • Eptifibatide (Integrilin) Injection (New - Discontinuation)
  • Hydroxyzine Pamoate Oral Capsules (New - Currently in Shortage)
  • Nystatin Cream, USP (New - Discontinuation)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Valacyclovir Hydrochloride Tablets (New - Discontinuation)
  • Vincristine Sulfate Injection, USP (Preservative-Free) (Updated - Currently in Shortage)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• 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)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry
• Warning Letters 2019 (Updated)

November 14, 2019

• FDA Drug Shortages
  • Eptifibatide (Integrilin) Injection (New - Discontinuation)
  • Nystatin Cream, USP (New - Discontinuation)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Public Notification: Power Khan Contains Hidden Drug Ingredient

November 13, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Public Notifications:
  • Man Erect contains hidden drug ingredient
  • SHENGDA contains hidden drug ingredient

November 12, 2019

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Cefotetan Disodium Injection (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Eptifibatide (Integrilin) Injection (New - Discontinuation)
  • Flurazepam Hydrochloride Capsules (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Oxytocin Injection, USP Synthetic (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Quinapril Hydrochloride (Accupril) Tablets (New - Discontinuation)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)
  • Thiothixene Capsules (Updated - Currently in Shortage)
  • Vinblastine Sulfate Injection (Updated - Currently in Shortage)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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