CDER New November 24, 2015

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What's New on the FDA Drugs Site

 

November 23, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

November 20, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Atripla	efavirenz; emtricitabine; tenofovir disoproxil fumarate	Tablet;Oral	Gilead	Labeling Revision
Azulfidine	sulfasalazine	Tablet;Oral	Pharmacia and Upjohn	Manufacturing Change or Addition
Azulfidine En-Tabs	sulfasalazine	Tablet, Delayed Release;Oral	Pharmacia and Upjohn	Manufacturing Change or Addition
Caldolor	ibuprofen	Solution;Intravenous	Cumberland Pharms	Supplement
Crestor	rosuvastatin calcium	Tablet;Oral	Ipr	Efficacy Supplement with Clinical Data to Support
Dextrose 10% In Plastic Container	dextrose	Injectable;Injection	B Braun	Manufacturing Change or Addition
Dextrose 2.5% In Plastic Container	dextrose	Injectable;Injection	B Braun	Manufacturing Change or Addition
Dextrose 5% In Plastic Container	dextrose	Injectable;Injection	B Braun	Manufacturing Change or Addition
Dextrose 7.7% In Plastic Container	dextrose	Injectable;Injection	B Braun	Manufacturing Change or Addition
Elelyso	taliglucerase alfa	Powder;Iv (Infusion)	Pfizer	Efficacy Supplement with Clinical Data to Support
Mekinist	trametinib dimethyl sulfoxide	Tablet;Oral	Novartis Pharms Corp	Supplement
Methotrexate Lpf	methotrexate sodium	Injectable;Injection	Hospira	Labeling Revision
Methotrexate Preservative Free	methotrexate sodium	Injectable;Injection	Hospira	Labeling Revision
Methotrexate Sodium	methotrexate sodium	Injectable;Injection	Hospira	Labeling Revision
Methotrexate Sodium Preservative Free	methotrexate sodium	Injectable;Injection	Hospira	Labeling Revision
Ninlaro	ixazomib	Capsule;Oral	Millennium Pharms	Approval
Pradaxa	dabigatran etexilate mesylate	Capsule;Oral	Boehringer Ingelheim	Efficacy Supplement with Clinical Data to Support
Tafinlar	dabrafenib mesylate	Capsule;Oral	Novartis Pharms Corp	Supplement
Xeomin	incobotulinumtoxina	Injectable; Injection	Merz Pharms	Manufacturing Change or Addition
Zantac 150	ranitidine hydrochloride	Tablet;Oral	Boehringer Ingelheim	Labeling Revision
Zantac 75	ranitidine hydrochloride	Tablet;Oral	Boehringer Ingelheim	Labeling Revision

 

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— Tuesday, November 24, 2015 — Add Comment