New and Generic Drug Approvals
October 29, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bio-Tropin | somatropin recombinant | Injectable;Injection | Ferring | Labeling Revision |
| Dymista | azelastine hydrochloride; fluticasone propionate | Spray, Metered;Nasal | Meda Pharms | Manufacturing Change or Addition |
| Edluar | zolpidem tartrate | Tablet;Sublingual | Meda Pharms | Labeling Revision |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | Trustees Of The U Of Penn | Approval |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | Childrens Hospital Of Mi | Approval |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | Centre For Probe Dev and Commercialization | Approval |
| Humira | adalimumab | Syringe | Abbvie Inc | Labeling Revision |
| Humira | adalimumab | Vial | Abbvie Inc | Labeling Revision |
| Letairis | ambrisentan | Tablet;Oral | Gilead | Supplement |
| Naropin | ropivacaine hydrochloride | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Piperacillin and Tazobactam | piperacillin;tazobactam | Injectable;Injection | Sandoz Inc | Approval |
| Singulair | montelukast sodium | Tablet, Chewable;Oral | Merck | Manufacturing Change or Addition |
| Sodium Fluoride F18 | sodium fluoride f18 | Injectable;Injection | Essential Isotopes Llc | Approval |
| Tev-Tropin | somatropin recombinant | Injectable;Injection | Ferring | Labeling Revision |
| Xigduo Xr | dapagliflozin;metformin hydrochloride | Tablet, Extended Release;Oral | Astrazeneca Ab | Approval |
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