What's New on the FDA Drugs Site
December 29, 2014
- Bioequivalence Recommendations for Specific Products (Updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
December 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abstral | fentanyl citrate | Tablet;Sublingual | Galena Biopharma | Supplement |
| Actiq | fentanyl citrate | Troche/Lozenge;Transmucosal | Cephalon | Supplement |
| Capoten | captopril | Tablet;Oral | Par Pharm | Labeling Revision |
| Fentora | fentanyl citrate | Tablet;Buccal, Sublingual | Cephalon | Supplement |
| Lazanda | fentanyl citrate | Spray, Metered;Nasal | Depomed Inc | Labeling Revision |
| Lazanda | fentanyl citrate | Spray, Metered;Nasal | Depomed Inc | Supplement |
| Lotrel | amlodipine besylate; benazepril hydrochloride | Capsule;Oral | Novartis | Labeling Revision |
| Mavik | trandolapril | Tablet;Oral | Abbvie | Labeling Revision |
| Onsolis | fentanyl citrate | Film;Buccal | Meda Pharms | Supplement |
| Subsys | fentanyl | Spray;Sublingual | Insys Therap | Labeling Revision |
| Subsys | fentanyl | Spray;Sublingual | Insys Therap | Supplement |
| Tarka | trandolapril; verapamil hydrochloride | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Vaseretic | enalapril maleate; hydrochlorothiazide | Tablet;Oral | Valeant Intl | Labeling Revision |
| Vasotec | enalapril maleate | Tablet;Oral | Valeant Intl | Labeling Revision |
| Zestoretic | hydrochlorothiazide; lisinopril | Tablet;Oral | Astrazeneca | Labeling Revision |
| Zestril | lisinopril | Tablet;Oral | Astrazeneca | Labeling Revision |
| Zyban | bupropion hydrochloride | Tablet, Extended Release;Oral | Glaxosmithkline | Labeling Revision |
December 23, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Depocyt | cytarabine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Labeling Revision |
| Dyloject | diclofenac sodium | Injectable;Injection | Javelin Pharms Inc | Approval |
| Namzaric | memantine hydrochloride;donepezil hydrochloride | Capsule;Oral | Forest Labs Inc | Approval |
| Neulasta | pegfilgrastim | Syringe | Amgen | Manufacturing Change or Addition |
| Retrovir | zidovudine | Capsule;Oral | Viiv Hlthcare | Labeling Revision |
| Retrovir | zidovudine | Syrup;Oral | Viiv Hlthcare | Labeling Revision |
| Retrovir | zidovudine | Injectable;Injection | Viiv Hlthcare | Labeling Revision |
| Retrovir | zidovudine | Tablet;Oral | Viiv Hlthcare | Labeling Revision |
| Taclonex | betamethasone dipropionate; calcipotriene hydrate | Ointment;Topical | Leo Pharma As | Efficacy Supplement with Clinical Data to Support |
| Tylenol | acetaminophen | Tablet, Extended Release;Oral | Mcneil Cons | Labeling Revision |
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