CDER New March 27, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

March 26, 2014


New and Generic Drug Approvals

March 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acephen acetaminophen Suppository;Rectal G and W Labs Labeling Revision
Adrenaclick epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Manufacturing Change or Addition
Emtriva emtricitabine Capsule;Oral Gilead Manufacturing Change or Addition
Estrogel estradiol Gel, Metered;Transdermal Ascend Labeling Revision
Estrogel estradiol Gel;Topical Ascend Labeling Revision
Femhrt ethinyl estradiol; norethindrone acetate Tablet;Oral Warner Chilcott Llc Manufacturing Change or Addition
Firmagon degarelix acetate Powder;Subcutaneous Ferring Manufacturing Change or Addition
Fludarabine Phosphate fludarabine phosphate Injectable;Injection Sandoz Manufacturing Change or Addition
Incivek telaprevir Tablet;Oral Vertex Pharms Manufacturing Change or Addition
Metro I.V. In Plastic Container metronidazole Injectable;Injection B Braun Manufacturing Change or Addition
Synarel nafarelin acetate Spray, Metered;Nasal Gd Searle Llc Manufacturing Change or Addition
Twinject 0.15 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Manufacturing Change or Addition
Twinject 0.3 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Manufacturing Change or Addition
Versacloz clozapine Suspension;Oral Jazz Pharms Iii Manufacturing Change or Addition
Viagra sildenafil citrate Tablet;Oral Pfizer Ireland Manufacturing Change or Addition
Zenpep pancrelipase (amylase;lipase;protease) Capsule, Delayed Release;Oral Aptalis Pharma Us Manufacturing Change or Addition

 


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