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FDA Approval Activities for this Drug… Fluoxetine Capsules USP, 10 mg and 20 mg, Ranbaxy Limited ANDA 76-165 2/1/02 4/11/03 Fluoxetine Capsules USP, 10 mg and 20 mg, Carlsbad Technology, ANDA 76-022 1/30/02 Fluoxetine Capsules USP, 10 mg, Dr. Reddy's Ltd. ANDA 76-006 1/30/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Sidmark , ANDA 76-001 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Sidmark , ANDA 76-001 10/16/01 Fluoxetine Capsules USP, 10 mg and 20 mg, Eon Labs Manufacturing, ANDA 75-807 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Eon Labs Manufacturing, ANDA 75-807 9/12/01 Fluoxetine Capsules USP, 10 mg and 20 mg, Mutual Pharmaceutical Co. ANDA 75-787 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Chelsea , ANDA 75-662 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Chelsea , ANDA 75-662 9/17/01 Fluoxetine Capsules USP, 10 mg and 20 mg, Mallinckrodt, ANDA 75-658 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Mallinckrodt, ANDA 75-658 6/16/00 11/7/00 Fluoxetine Capsules USP, 10 mg and 20 mg, Alphapharm Pty. Ltd. ANDA 75-577 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Alphapharm Pty. Ltd. ANDA 75-577 2/6/01 3/5/01 Fluoxetine Capsules USP, 10, 20 and 40 mg, Dr. Reddy's Limited ANDA 75-465 1/30/02 6/11/02 Fluoxetine Capsules USP, 10, 20 and 40 mg, Dr. Reddy's Limited ANDA 75-465 6/26/01 8/2/01 Fluoxetine Capsules USP, 40 mg Dr. Reddy's Limited ANDA 75-465 8/2/01 8/6/01 1/17/02 1/17/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Ganes Chemicals for Siegfried, Ltd. ANDA 75-464 1/30/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Apothecon ANDA 75-464 2/2/01 3/5/01 Fluoxetine Capsules USP, 10 mg and 20 mg, Teva USA ANDA 75-452 1/29/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Teva USA ANDA 75-452 1/3/00 1/19/00 Fluoxetine Capsules USP, 10 mg (base) and 20 mg (base), Ivax ANDA 75-245 1/31/02 Fluoxetine Capsules USP, 10 mg (base) and 20 mg (base), Zenith Goldline Inc ANDA 75-245 10/18/99 12/30/99 Fluoxetine Capsules USP, 10 mg and 20 mg, Mylan ANDA 75-207 1/30/02 Fluoxetine Capsules USP, 10 mg and 20 mg, Mylan ANDA 75-207 2/26/99 3/4/99 Fluoxetine Capsules USP, 20 & 40 mg, Geneva ANDA 75-049 S01-S10 1/29/02 4/9/03 Fluoxetine Capsules USP, 10 mg Geneva ANDA 75-049 8/2/01 8/2/01 8/6/03 Fluoxetine Capsules USP, 10 mg and 20 mg, Barr ANDA 74-803 6/14/00 6/16/00 8/5/03 Fluoxetine Capsules USP, 10 mg. Barr, ANDA 74-803 1/30/02 6/11/02 6/11/02 6/11/02 Fluoxetine Capsules USP, 10 & 20 mg. Barr, ANDA 74-803 8/2/01 8/2/01 Fluoxetine Solution, 20 mg (base)/5 mL, ESI Lederle ANDA 76-016 8/24/01 4/16/03 Fluoxetine Solution, 20 mg (base)/5 mL, Pharmaceutical Associates ANDA 76-015 1/30/02 Fluoxetine Solution, 20 mg (base)/5 mL, Mallinckrodt, ANDA 75-920 1/29/02 Fluoxetine Solution, 20 mg (base)/5 mL, Mallinckrodt, ANDA 75-920 9/28/01 Fluoxetine Solution USP, 20 mg/5 mL, Alpharma ANDA 75-690 1/31/02 Fluoxetine Solution USP, 20 mg/5 mL, Alpharma ANDA 75-690 5/10/01 6/5/01 Fluoxetine Solution USP, 20 mg/5ml, Hi-Tech Pharmacal Co., ANDA 75-525 6/27/02 Fluoxetine Solution USP, 20 mg/5ml, Morton Grove ANDA 75-514 8/29/02 Fluoxetine Solution USP, 20 mg/5ml Teva USA ANDA 75-506 8/2/01 8/2/01 1/17/02 Fluoxetine Hydrochloride Solution, 20 mg (base)/5 mL, Apotex Corp. ANDA 75-292 2/7/02 4/10/03 Fluoxetine Hydrochloride Solution, 20 mg (base)/5 mL, Novex Pharma ANDA 75-292 9/1/00 10/30/00 Fluoxetine Hydrochloride Tablets, 10 mg (base), Eon Labs Manufacturing, ANDA 76-024 1/29/02 Fluoxetine Hydrochloride Tablets, 10 mg (base), Eon Labs Manufacturing, ANDA 76-024 9/12/01 Fluoxetine Hydrochloride Tablets, 10 mg (base), Dr. Reddy's Ltd. ANDA 76-006 8/23/01 Fluoxetine Hydrochloride Tablets, 10 mg (base), Teva ANDA 75-872 1/29/02 Fluoxetine Hydrochloride Tablets, 10 mg (base), Teva ANDA 75-872 5/31/01 6/5/01 Fluoxetine Hydrochloride Tablets, 10 mg, Zenith Goldline ANDA 75-865 2/28/02 Fluoxetine Hydrochloride Tablets, 10 mg, Barr laboratories ANDA 75-810 2/1/02 Fluoxetine Hydrochloride Tablets, 10 mg, Barr laboratories ANDA 75-810 8/31/01 4/15/03 Fluoxetine Hydrochloride Tablets, 10 mg and 20 mg. Alphapharm Pty. Ltd. ANDA 75-755 8/2/01 8/2/01 8/6/03 Fluoxetine Hydrochloride Tablets, 10 & 20 mg (base), Alphapharm Pty. Ltd. ANDA 75-755 Prozac (fluoxetine HCl) Capsules, Lilly NDA 18-936/SE5-064 01/03/03 1/23/03 9/25/03 Indication: Major Depressive Disorder (MDD) and Obsessive Compulsive Disorder (OCD) in the pediatric population (7-17 years old) Prozac (fluoxetine HCl .) Capsules, 90 mg, Eli Lilly NDA 21-235 2/26/01 3/30/01 3/30/01 Prozac (fluoxetine HCl .) Capsules, Solution & Tablets, Eli Lilly & Company NDA 18-936/S61, S65, 20-101/S27 & 20-974/S1 7/29/02 8/6/02 7/30/02 Prozac (fluoxetine HCl .) Tablets, 10 mg & 20 mg, Lilly Research NDA 20-974 3/9/99 3/11/99 8/30/01 Prozac Indication: Depression, OCD, Bulimia Nervosa Sarafem (fluoxetine hydrochloride) Capsules, Eli Lilly and Company, NDA 18-936/S-067 6/12/02 6/14/02 6/12/02 Sarafem (Fluoxetine HC1) Capsules,Rx Lilly NDA 18-936/SE1-058 7/6/00 7/6/00 7/6/00 Sarafem Indications: Premenstrual Dysphoric Disorder (PMDD). FLUOXETINE HYDROCHLORIDE Capsule, Delayed Rel Pellets; 90MG BASE PROZAC WEEKLY LILLY 075577 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Alphapharm 075577 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Alphapharm 074803 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Barr 074803 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Barr 076022 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE CARLSBAD 076022 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE CARLSBAD 075465 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE DR REDDYS INC 075465 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE DR REDDYS INC 075465 FLUOXETINE HYDROCHLORIDE Capsule; 40MG BASE FLUOXETINE DR REDDYS INC 075807 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Eon 075807 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Eon 075049 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Geneva 075049 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE HCL Geneva 075049 FLUOXETINE HYDROCHLORIDE Capsule; 40MG BASE FLUOXETINE HCL Geneva 075245 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Ivax 075245 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Ivax 018936 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE PROZAC LILLY 018936 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE SARAFEM LILLY 018936 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE SARAFEM LILLY 018936 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE PROZAC LILLY 018936 FLUOXETINE HYDROCHLORIDE Capsule; 40MG BASE PROZAC LILLY 075658 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Mallinckrodt 075658 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Mallinckrodt 075787 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Mutual 075787 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Mutual 075207 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Mylan 075207 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Mylan 076001 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Pliva 076001 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Pliva 076165 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Ranbaxy 076165 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Ranbaxy 075464 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE SIEGFRIED 075464 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE SIEGFRIED 075452 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Teva 075452 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Teva 075452 FLUOXETINE HYDROCHLORIDE Capsule; 40MG BASE FLUOXETINE Teva 075662 FLUOXETINE HYDROCHLORIDE Capsule; 10MG BASE FLUOXETINE Watson 075662 FLUOXETINE HYDROCHLORIDE Capsule; 20MG BASE FLUOXETINE Watson 075690 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE ALPHARMA 075525 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE HCL HI TECH 020101 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML PROZAC LILLY 075920 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE Mallinckrodt 075514 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE HCL Morton Grove 075292 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE Novex 076015 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE ASSOC 075506 FLUOXETINE HYDROCHLORIDE Solution; 20MG BASE/5ML FLUOXETINE Teva 075755 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE FLUOXETINE HCL Alphapharm 075755 FLUOXETINE HYDROCHLORIDE Tablet; 20MG BASE FLUOXETINE HCL Alphapharm 075810 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE FLUOXETINE HCL Barr 076006 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE FLUOXETINE HCL DR REDDYS INC 076024 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE FLUOXETINE HCL Eon 020974 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE PROZAC LILLY 075872 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE FLUOXETINE HCL Teva 075865 FLUOXETINE HYDROCHLORIDE Tablet; 10MG BASE FLUOXETINE HCL ZENITH GOLDLINE Fluoxetine Oral Solution, Par Pharmaceutical Prozac (fluoxetine hydrochloride) Oral Solution, Eli Lilly and Company Prozac (fluoxetine hydrochloride) pulvules, Eli Lilly, Labeling Revision Prozac Delayed-Release Capsules, Eli Lilly, Labeling Revision Prozac solution, Eli Lilly, Labeling Revision Prozac tablets, Eli Lilly, Labeling Revision Sarafem (fluoxetine hydrochloride) pulvules, Eli Lilly, Labeling Revision | Fluoxetine Capsules, Ranbaxy Labs, Approval | Prozac and Sarafem (fluoxetine hydrochloride) pulvules, Eli Lilly and Co., Labeling Revision | Prozac solution, Eli Lilly and Co., Labeling Revision | Prozac tablets, Eli Lilly and Co., Labeling Revision | Prozac Delayed-Release Capsules, Eli Lilly and Co., Labeling Revision Find the latest approval information using this index.   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Find API by Brand Name | FindingHealthOnline | API News | Prescription Drug Websites | Forum (Q & A)     © 2009 Betterchem.com