CDER New: 9/10/2020

What's New Related to Drugs

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

September 9, 2020

• FDA Drug Shortages
  • Etomidate Injection (Updated - Currently in Shortage)
  • Hydralazine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
• FDA requests notification of stakeholder intent to participate in consultation meetings on GDUFA Reauthorization

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 9, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Depo-Provera NDA #020246	Medroxyprogesterone Acetate	Injectable; Injection	SUPPL-57	Pharmacia and Upjohn	Labeling	Approved
Depo-Provera NDA #020246	Medroxyprogesterone Acetate	Injectable; Injection	SUPPL-43	Pharmacia and Upjohn	Labeling	Approved
Ceftriaxone and Dextrose In Duplex Container NDA #050796	Ceftriaxone Sodium	Injectable; Injection	SUPPL-23	B Braun	Labeling	Approved
Trelegy Ellipta NDA #209482	Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate	Powder; Inhalation	SUPPL-10	Glaxosmithkline	Efficacy	Approved
Trelegy Ellipta NDA #209482	Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate	Powder; Inhalation	SUPPL-11	Glaxosmithkline	Labeling	Approved

September 8, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Diflucan NDA #019949	Fluconazole	Tablet; Oral	SUPPL-69	Pfizer	Labeling	Approved
Diflucan In Dextrose 5% In Plastic Container NDA #019950	Fluconazole	Injectable; Injection	SUPPL-68	Pfizer	Labeling	Approved
Diflucan In Sodium Chloride 0.9% NDA #019950	Fluconazole	Injectable; Injection	SUPPL-68	Pfizer	Labeling	Approved
Diflucan In Sodium Chloride 0.9% In Plastic Container NDA #019950	Fluconazole	Injectable; Injection	SUPPL-68	Pfizer	Labeling	Approved
Diflucan NDA #020090	Fluconazole	For Suspension; Oral	SUPPL-50	Pfizer	Labeling	Approved
Bimatoprost ANDA #202505	Bimatoprost	Solution/Drops; Ophthalmic	ORIG-1	Micro Labs		Approved