CDER New April 22, 2016

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New and Generic Drug Approvals

April 20, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Belbuca	buprenorphine hydrochloride	Film;Buccal	Endo Pharms Inc	Supplement
Butrans	buprenorphine	Film, Extended Release;Transdermal	Purdue Pharma Lp	Supplement
Dolophine Hydrochloride	methadone hydrochloride	Syrup;Oral	Roxane	Supplement
Dolophine Hydrochloride	methadone hydrochloride	Tablet;Oral	Roxane	Supplement
Duragesic-100	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-12	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-25	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-50	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Duragesic-75	fentanyl	Film, Extended Release;Transdermal	Janssen Pharms	Supplement
Embeda	morphine sulfate; naltrexone hydrochloride	Capsule, Extended Release;Oral	Alpharma Pharms	Supplement
Exalgo	hydromorphone hydrochloride	Tablet, Extended Release;Oral	Mallinckrodt Inc	Supplement
Gilotrif	afatinib dimaleate	Tablet;Oral	Boehringer Ingelheim	Labeling Revision
Hysingla	hydrocodone bitartrate	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Kadian	morphine sulfate	Capsule, Extended Release;Oral	Actavis Labs Ut Inc	Supplement
Liothyronine Sodium	liothyronine sodium	Tablet;Oral	Sun Pharm Inds Ltd	Approval
Morphabond	morphine sulfate	Tablet, Extended Release;Oral	Idt	Supplement
Ms Contin	morphine sulfate	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Nucynta Er	tapentadol hydrochloride	Tablet, Extended Release;Oral	Depomed Inc	Supplement
Opana Er	oxymorphone hydrochloride	Tablet, Extended Release;Oral	Endo Pharms	Supplement
Opana Er	oxymorphone hydrochloride	Tablet, Extended Release;Oral	Endo Pharms	Supplement
Oxaliplatin	oxaliplatin	Injectable;Iv (Infusion)	Teva Pharms	Labeling Revision
Oxycontin	oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Targiniq	naloxone hydrochloride; oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Supplement
Zohydro Er	hydrocodone bitartrate	Capsule, Extended Release;Oral	Pernix Ireland Pain	Supplement

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