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