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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
For the most up-to-date approval information, please locate this API using the drug index.
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