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FDA Approval Activities for this Drug… Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate/ethinyl estradiol), Pharmacia & Upjohn NDA 20-874 Medroxyprogesterone Acetate Tablets USP, 2.5 mg, 5 mg, and 10 Duramed ANDA 40-311 Provera (Medroxyprogesterone Acetate Tablets, 5 & 10 mg, Pharmacia & Upjohn NDA 11839/S-068 8/4/98 9/17/98 8/6/01 Provera Indication: The reduction of endometrial hypeplasia in postmenopausal women receiving 0.625mg conjugated estrogens for 12 to 14 consecutive days per month, either beginning on the 1st day of the cycle or the 16th day of the cycle. Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, Wyeth-Ayerst NDA 21-396 6/4/03 6/9/03 6/9/03 Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, Wyeth NDA 20527/S24, S26, S31 6/4/03 Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, Wyeth-Ayerst NDA 20527/S030 1/7/03 1/7/03 1/7/03 Prempro/conjugated estrogens /medroxyprogeterone acetate Tablets, Wyeth-Ayerst NDA 20527/S029 11/27/02 12/9/02 12/4/02 Prempro/conjugated estrogens /medroxyprogeterone acetate Tablets Wyeth-Ayerst NDA 20527/S006 1/9/98 5/6/98 7/13/00 Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, Wyeth-Ayerst NDA 20527/S018 2/11/02 3/8/02 Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, Wyeth NDA 20527/S017 3/12/03 3/18/03 3/25/03 9/11/03 Prempro/Premphase (conjugated estrogens /medroxyprogeterone acetate) Tablets, ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Tablet; -28 0.3MG;1.5MG PREMPRO Wyeth INC 020527 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Tablet; -28 0.45MG;1.5MG PREMPRO Wyeth INC 020527 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Tablet; -28 0.625MG;0.625MG;2.5MG;2.5MG PREMPRO Wyeth INC 020527 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Tablet; -28 0.625MG;0.625MG;5MG PREMPHASE 14/14 Wyeth INC 020527 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Tablet; -28 0.625MG;0.625MG;5MG;5MG PREMPRO Wyeth INC 020246 MEDROXYPROGESTERONE ACETATE Injection 150MG/ML DEPO-PROVERA PHARMACIA AND UPJOHN 012541 MEDROXYPROGESTERONE ACETATE Injection 400MG/ML DEPO-PROVERA PHARMACIA AND UPJOHN 040159 MEDROXYPROGESTERONE ACETATE Tablet; 10MG MEDROXYPROGESTERONE ACETATE Barr 040159 MEDROXYPROGESTERONE ACETATE Tablet; 2.5MG MEDROXYPROGESTERONE ACETATE Barr 040159 MEDROXYPROGESTERONE ACETATE Tablet; 5MG MEDROXYPROGESTERONE ACETATE Barr 040311 MEDROXYPROGESTERONE ACETATE Tablet; 10MG MEDROXYPROGESTERONE ACETATE DURAMED Barr 040311 MEDROXYPROGESTERONE ACETATE Tablet; 2.5MG MEDROXYPROGESTERONE ACETATE DURAMED Barr 040311 MEDROXYPROGESTERONE ACETATE Tablet; 5MG MEDROXYPROGESTERONE ACETATE DURAMED Barr 011839 MEDROXYPROGESTERONE ACETATE Tablet; 10MG PROVERA PHARMACIA AND UPJOHN 011839 MEDROXYPROGESTERONE ACETATE Tablet; 2.5MG PROVERA PHARMACIA AND UPJOHN 011839 MEDROXYPROGESTERONE ACETATE Tablet; 5MG PROVERA PHARMACIA AND UPJOHN 088484 BP MEDROXYPROGESTERONE ACETATE Tablet; 10MG MEDROXYPROGESTERONE ACETATE USL Prempro/Premphase (conjugated estrogens / medroxyprogesterone acetate) Tablets, Wyeth Pharmaceuticals Medroxyprogesterone Acetate Injectable Suspension, Sicor, Approval | Medroxyprogesterone Acetate Injectable Suspension, Sicor Pharma, Approval | Depo-subQ Provera 104 (Medroxyprogesterone Acetate) Injectable, Pfizer, Approval | Depo-subQ Provera 104 (Medroxyprogesterone acetate) Injectable Suspension, Pfizer, Approval | Depo-SubQ Provera 104 Injectable Suspension, Pfizer, Labeling Revision | PREMPRO/PREMPHASE (conjugated estrogens/medroxyprogesterone acetate) tablets, Wyeth Pharma, Labeling Revision | Depo-Provera Contraceptive Injection, Pfizer Global, Labeling Revision | Prempro/Premphase Tablets, Wyeth Pharma, Labeling Revision Visit Betterchem's Drug Index for FDA's latest approval information.   Find other drugs… A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | USActives.com | Pharma Job Search | Pharma Company News © 2011 FindingHealthOnline™