CDER New July 6, 2017

What's New on the FDA Drugs Site

July 5, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dexrazoxane (Zinecard) Injection (New - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

July 5, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Dexmethylphenidate Hydrochloride ANDA #202731	Dexmethylphenidate Hydrochloride	Capsule, Extended Release; Oral	ORIG-3	Teva Pharms Usa		Approved
Dexmethylphenidate Hydrochloride ANDA #203614	Dexmethylphenidate Hydrochloride	Capsule, Extended Release; Oral	ORIG-1	Impax Labs Inc		Approved
Promacta NDA #022291	Eltrombopag Olamine	Tablet; Oral	SUPPL-18	Novartis Pharms Corp	Labeling	Approved
Promacta NDA #207027	Eltrombopag Olamine	For Suspension; Oral	SUPPL-3	Novartis Pharms Corp	Labeling	Approved

July 3, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Cytovene NDA #019661	Ganciclovir Sodium	Injectable; Injection	SUPPL-36	Roche Palo	Labeling	Approved
Ephedrine Sulfate NDA #208609	Ephedrine Sulfate	Solution; Intravenous	SUPPL-1	Akorn Inc	Manufacturing (CMC)	Approved
Ephedrine Sulfate NDA #208609	Ephedrine Sulfate	Solution; Intravenous	SUPPL-1	Akorn Inc	Manufacturing (CMC)	Approved
Metformin Hydrochloride; Sitagliptin Phosphate ANDA #208535	Metformin Hydrochloride;Sitagliptin Phosphate	Tablet; Oral	ORIG-1	Zydus Pharms Usa Inc		Tentative Approval
Omeprazole ANDA #203481	Omeprazole	Capsule, Delayed Rel Pellets; Oral	ORIG-1	Breckenridge Pharm		Approved
Quetiapine Fumarate ANDA #202674	Quetiapine Fumarate	Tablet; Oral	SUPPL-5	Unichem Labs Ltd	Manufacturing (CMC)	Approved
Quetiapine Fumarate ANDA #202674	Quetiapine Fumarate	Tablet; Oral	SUPPL-5	Unichem Labs Ltd	Manufacturing (CMC)	Approved
Quetiapine Fumarate ANDA #202674	Quetiapine Fumarate	Tablet; Oral	SUPPL-5	Unichem Labs Ltd	Manufacturing (CMC)	Approved

 

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— Thursday, July 6, 2017 — Add Comment