New and Generic Drug Approvals
August 18, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abilify | aripiprazole | Tablet;Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Solution;Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Tablet, Orally Disintegrating;Oral | Otsuka | Labeling Revision |
| Abilify | aripiprazole | Injectable;Intramuscular | Otsuka | Labeling Revision |
| Abilify Maintena Kit | aripiprazole | For Suspension, Extended Release;Intramuscular | Otsuka Pharm Co Ltd | Labeling Revision |
| Aristada | aripiprazole lauroxil | Suspension, Extended Release;Intramuscular | Alkermes Inc | Labeling Revision |
| Glucotrol | glipizide | Tablet;Oral | Pfizer | Labeling Revision |
| Motrin Ib | ibuprofen | Tablet;Oral | J and J Consumer Inc | Labeling Revision |
| Motrin Migraine Pain | ibuprofen | Tablet;Oral | J and J Consumer Inc | Labeling Revision |
| Nuprin | ibuprofen | Tablet;Oral | J and J Consumer Inc | Labeling Revision |
| Trokendi Xr | topiramate | Capsule, Extended Release;Oral | Supernus Pharms | Efficacy Supplement with Clinical Data to Support |
| Trokendi Xr | topiramate | Capsule, Extended Release;Oral | Supernus Pharms | Tentative Approval |
Searching the Orange Book is now faster and easier with our new mobile app!
Download Orange Book Express
| This email was sent to rssproject471@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332) |  |
—
Monday, August 22, 2016
—
Add Comment
Belum ada tanggapan untuk "CDER New August 22, 2016"
Post a Comment