CDER New April 3, 2013

What's New on the FDA Drugs Site

April 2, 2013

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Guidance for Industry:
  • Comprehensive List of Guidance Documents  (PDF - 641KB) 
  • New Revised Withdrawn List of Guidance Documents  (PDF - 52KB) 
  • Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 (PDF - 98KB)
• National Drug Code Directory (updated)

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New and Generic Drug Approvals

April 1, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cutivate	fluticasone propionate	Lotion; Topical	Fougera Pharms	Manufacturing Change or Addition
Naproxen Sodium	naproxen sodium	Capsule; Oral	Banner Pharmacaps	Labeling Revision
Nimbex	cisatracurium besylate	Injectable; Injection	Abbvie	Manufacturing Change or Addition
Nimbex Preservative Free	cisatracurium besylate	Injectable; Injection	Abbvie	Manufacturing Change or Addition
Pepcid Ac	famotidine	Tablet; Oral	Mcneil Cons	Manufacturing Change or Addition
Pepcid Ac	famotidine	Tablet, Chewable; Oral	Mcneil Cons	Manufacturing Change or Addition
Pepcid Complete	calcium carbonate; famotidine; magnesium hydroxide	Tablet, Chewable; Oral	Mcneil Cons	Manufacturing Change or Addition
Velcade	bortezomib	Injectable; Intravenous, Subcutaneous	Millennium Pharms	Manufacturing Change or Addition

 

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