CDER New July 31, 2013

What's New on the FDA Drugs Site

July 30, 2013

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry: Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act (PDF - 118KB)
• National Drug Code Directory 

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New and Generic Drug Approvals

July 29, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Celebrex	celecoxib	Capsule; Oral	Gd Searle	Manufacturing Change or Addition
Doxycycline	doxycycline	Capsule; Oral	Lupin Ltd	Tentative Approval
Edarbi	azilsartan kamedoxomil	Tablet; Oral	Takeda Pharms Usa	Manufacturing Change or Addition
Eletriptan Hydrobromide	eletriptan hydrobromide	Tablet; Oral	Apotex Inc	Tentative Approval
Ranolazine	ranolazine	Tablet, Extended Release; Oral	Lupin Ltd	Approval
Sprix	ketorolac tromethamine	Spray, Metered; Nasal	Luitpold	Manufacturing Change or Addition
Teflaro	ceftaroline fosamil	Powder; Iv (Infusion)	Cerexa	Manufacturing Change or Addition
Tegretol-Xr	carbamazepine	Tablet, Extended Release; Oral	Novartis	Manufacturing Change or Addition
Ultravist 150	iopromide	Injectable; Injection	Bayer Hlthcare	Manufacturing Change or Addition
Ultravist 240	iopromide	Injectable; Injection	Bayer Hlthcare	Manufacturing Change or Addition
Ultravist 300	iopromide	Injectable; Injection	Bayer Hlthcare	Manufacturing Change or Addition
Ultravist 300 In Plastic Container	iopromide	Injectable; Injection	Bayer Hlthcare	Manufacturing Change or Addition
Ultravist 370	iopromide	Injectable; Injection	Bayer Hlthcare	Manufacturing Change or Addition
Vivitrol	naltrexone	For Suspension, Extended Release; Intramuscular	Alkermes	Labeling Revision

 

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