New and Generic Drug Approvals
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Atnaa | atropine; pralidoxime chloride | Injectable;Intramuscular | Us Army | Manufacturing Change or Addition |
Claritin | loratadine | Syrup;Oral | Schering Plough | Manufacturing Change or Addition |
Claritin Hives Relief | loratadine | Syrup;Oral | Schering Plough | Manufacturing Change or Addition |
Desonide | desonide | Cream;Topical | Perrigo New York | Manufacturing Change or Addition |
Invokana | canagliflozin | Tablet;Oral | Janssen Pharms | Labeling Revision |
Izba | travoprost | Solution;Ophthalmic | Alcon Labs Inc | Approval |
Lunesta | eszopiclone | Tablet;Oral | Sunovion Pharms Inc | Labeling Revision |
Nutropin Aq | somatropin recombinant | Injectable;Injection | Genentech | Manufacturing Change or Addition |
Nutropin Aq Pen | somatropin recombinant | Injectable;Injection | Genentech | Manufacturing Change or Addition |
Olanzapine | olanzapine | Tablet, Orally Disintegrating;Oral | Aurobindo Pharma Ltd | Approval |
Opana Er | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Endo Pharms | Manufacturing Change or Addition |
Oxytrol For Women | oxybutynin | Film, Extended Release;Transdermal | Msd Consumer | Manufacturing Change or Addition |
Prilosec Otc | omeprazole magnesium | Tablet, Delayed Release;Oral | Astrazeneca | Manufacturing Change or Addition |
Taxotere | docetaxel | Injectable;Injection | Sanofi Aventis Us | Manufacturing Change or Addition |
Trivagizole 3 | clotrimazole | Cream;Vaginal | Taro | Manufacturing Change or Addition |
Xarelto | rivaroxaban | Tablet; Oral | Janssen Pharms | Manufacturing Change or Addition |
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