CDER New August 11, 2015

What's New on the FDA Drugs Site

August 10, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Shortages 2 mobile app for Android devices adds alert feature
• National Drug Code Directory

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New and Generic Drug Approvals

August 8, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Synarel	nafarelin acetate	Spray, Metered;Nasal	Gd Searle Llc	Labeling Revision

 August 7, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Anoro Ellipta	umeclidinium bromide; vilanterol trifenatate	Powder;Inhalation	Glaxosmithkline	Manufacturing Change or Addition
Daranide	dichlorphenamide	Tablet;Oral	Taro	Efficacy Supplement with Clinical Data to Support
Furosemide	furosemide	Tablet;Oral	Ivax Sub Teva Pharms	Manufacturing Change or Addition
Imodium Multi-Symptom Relief	loperamide hydrochloride; simethicone	Tablet;Oral	Mcneil Cons	Manufacturing Change or Addition
Nymalize	nimodipine	Solution;Oral	Arbor Pharms Llc	Manufacturing Change or Addition
Omeprazole	omeprazole	Tablet, Delayed Release;Oral	Dexcel Pharma	Manufacturing Change or Addition
Priftin	rifapentine	Tablet;Oral	Sanofi Aventis Us	Manufacturing Change or Addition
Symlin	pramlintide acetate	Injectable;Subcutaneous	Astrazeneca Ab	Supplement
Technetium Tc 99m Generator	technetium tc-99m sodium pertechnetate generator	Solution;Intravenous, Oral	Ge Healthcare	Labeling Revision
Xenical	orlistat	Capsule;Oral	Hoffmann La Roche	Labeling Revision
Zipsor	diclofenac potassium	Capsule;Oral	Depomed Inc	Manufacturing Change or Addition

 

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— Tuesday, August 11, 2015 — Add Comment