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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