Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

cosal. EQ 0.6 mg Base; eq 0.8 mg Base; EQ 1.2 mg Base; EQ 1.6 mg Base. NDA 020757.......... AVAPRO........... Irbesartan....... 75 mg........... Tablet; Oral.... Sanofi-Aventis U.S. LLC. NDA 021065.......... FEMHRT........... Ethinyl 0.0025 mg; 0.5 Tablet; Oral.... Allergan Estradiol; mg. Pharmaceuticals Norethindrone International Acetate. Ltd. NDA 021087.......... TAMIFLU.......... Oseltamivir EQ 30 mg Base; Capsule; Oral... Roche. Phosphate. EQ 45 mg Base. [[Page 34635]] NDA 021227.......... CANCIDAS......... Caspofungin 50 mg/Vial; 70 Powder; Merck Sharp & Acetate. mg/Vial. Intravenous. Dohme. NDA 021506.......... MYCAMINE......... Micafungin Sodium EQ 50 mg Base/ Injectable; Astellas Pharma Vial; EQ 100 mg Intravenous. US Inc. Base/Vial. NDA 021520.......... SYMBYAX.......... Fluoxetine EQ 25 mg Base; Capsule; Oral... Eli Lilly and Hydrochloride; EQ 3 mg Base; Co. Olanzapine. EQ 25 mg Base; EQ 6 mg Base; EQ 25 mg Base; EQ 12 mg Base; EQ 50 mg Base; EQ 6 mg Base; EQ 50 mg Base; EQ 12 mg Base. NDA 021947.......... FENTORA.......... Fentanyl Citrate. EQ 0.1 mg Base; Tablet; Buccal, Cephalon, LLC. EQ 0.2 mg Base; Sublingual. EQ 0.4 mg Base; EQ 0.6 mg Base; EQ 0.8 mg Base. NDA 022076.......... LOCOID........... Hydrocortisone 0.1%............ Lotion; Topical. Bausch Health. Butyrate. NDA 022116.......... LEXIVA........... Fosamprenavir EQ 50 mg Base/mL Suspension; Oral ViiV Hea