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FDA Approval Activities for this Drug…
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, Premarin (conjugated estrogens) Tablets, USP, Wyeth NDA 21-417 7/16/03 7/28/03 9/25/03 Premarin (conjugated estrogens) Tablets, USP, Wyeth-Ayerst NDA 4-782/S115, S130 4/24/03 Premarin (conjugated estrogens) Tablets, USP, Wyeth-Ayerst NDA 4-782/S-129 1/7/03 1/7/03 1/7/03 Premarin (conjugated estrogens) Tablets, USP, Wyeth-Ayerst NDA 4-782/S-128 11/27/02 12/6/02 12/4/02 Premarin (conjugated estrogens) Tablets, USP, Wyeth-Ayerst NDA 4-782/S-125 7/16/03 7/28/03 Premarin Tablets USP Wyeth-Ayerst NDA 4-782/S-093 9/8/98 7/21/99 ESTROGENS, CONJUGATED Cream; Topical, Vaginal 0.625MG/GM PREMARIN Wyeth INC 010402 ESTROGENS, CONJUGATED Injection 25MG/VIAL PREMARIN Wyeth INC 004782 ESTROGENS, CONJUGATED Tablet; 0.3MG PREMARIN Wyeth INC 004782 ESTROGENS, CONJUGATED Tablet; 0.45MG PREMARIN Wyeth INC 004782 ESTROGENS, CONJUGATED Tablet; 0.625MG PREMARIN Wyeth INC 004782 ESTROGENS, CONJUGATED Tablet; 0.9MG PREMARIN Wyeth INC 004782 ESTROGENS, CONJUGATED Tablet; 1.25MG PREMARIN Wyeth INC 004782 ESTROGENS, CONJUGATED Tablet; 2.5MG PREMARIN Wyeth INC 020992 ESTROGENS, CONJUGATED SYNTHETIC A Tablet; 0.3MG CENESTIN DURAMED 020992 ESTROGENS, CONJUGATED SYNTHETIC A Tablet; 0.625MG CENESTIN DURAMED 020992 ESTROGENS, CONJUGATED SYNTHETIC A Tablet; 0.9MG CENESTIN DURAMED 020992 ESTROGENS, CONJUGATED SYNTHETIC A Tablet; 1.25MG CENESTIN DURAMED 020527 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 084951 ESTROGENS, ESTERIFIED Tablet; 0.3MG MENEST MONARCH 084948 ESTROGENS, ESTERIFIED Tablet; 0.625MG MENEST MONARCH 084950 ESTROGENS, ESTERIFIED Tablet; 1.25MG MENEST MONARCH 084949 ESTROGENS, ESTERIFIED Tablet; 2.5MG MENEST MONARCH Cenestin (synthetic conjugated estrogens, A) Tablets, Duramed Pharmaceuticals Premarin (conjugated estrogens) Tablets, USP, Wyeth Pharmaceuticals Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharmaceuticals Premarin Intravenous (conjugated estrogens) Injection, Wyeth Pharmaceuticals Prempro/Premphase (conjugated estrogens / medroxyprogesterone acetate) Tablets, Wyeth Pharmaceuticals Enjuvia (synthetic conjugated estrogens, B) tablets, Duramed Pharmaceuticals Premarin (conjugated estrogens tablets, Wyeth Pharmaceuticals, Formulation Revision | Cenestin (synthetic conjugated estrogens, A) Tablets, Duramed Pharma, Labeling Revision | Enjuvia (synthetic conjugated estrogens, B) tablets, Duramed Pharma, Approval | Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens) tablets, Wyeth Pharma, Labeling Revision | PREMPRO/PREMPHASE (conjugated estrogens/medroxyprogesterone acetate) tablets, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens) tablets, Wyeth Pharma, Formulation Revision | Premarin (conjugated estrogens) tablets, Wyeth Pharma, Formulation Revision | Premarin (conjugated estrogens) tablets, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens, USP) Injection, Wyeth Pharma, Control Supplement | Premarin (conjugated estrogens) Injection, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharma, Labeling Revision | Prempro/Premphase Tablets, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens tablets USP) Tablets, Wyeth Pharma, Labeling Revision | Enjuvia (synthetic conjugated estrogens, B) Tablets, Duramed Research, New or Modified Indication | Enjuvia (synthetic conjugated estrogens, B) Tablets, Duramed Pharma, Control Supplement | Premarin (Conjugated Estrogens) Cream, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens) Tablets, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharma, Labeling Revision | Premarin Intravenous (conjugated estrogens) Injection, Wyeth Pharma, Labeling Revision | Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate) Tablets, Wyeth Pharma, Labeling Revision | Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharmaceuticals Inc., New or Modified Indication | Synthetic Conjugated Estrogens Vaginal Cream, Duramed Research, Inc., Approval | Synthetic Conjugated Estrogens, Vaginal Cream, Duramed Research, Inc, Approval | Prempro (estrogens, conjugated and medroxyprogesterone acetate) Tablets, Wyeth Pharmaceuticals Inc., Formulation Revision | Prempro (estrogens, conjugated and medroxyprogesterone acetate) Tablets, Wyeth Pharmaceuticals Inc., Labeling Revision | Premarin (conjugated estrogens) Vaginal Cream, Pfizer Inc., Labeling Revision | Premarin (conjugated estrogens) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  
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