FDA Approval Activities for this Drug…

Progesterone Injection USP, 50 mg/mL, packaged in 10 mL multiple-dose vial, American Pharmaceutical Partners, ANDA 75-906 Prometrium (progesterone USP) Capsules, 100 mg Schering-Plough Research Institute NDA 19-781 5/14/98 5/15/98 5/15/98 1/6/99 Prometrium (progesterone, USP) Capsules, 100 mg, Schering NDA 20-843 12/16/98 12/17/98 12/17/98 Prometrium Indication: For use in the prevention of endometrial hyperplasia in nonhysterectomized post-menopausal women who are receiving conjugated estrogens tablets. Prochieve (progesterone gel), Columbia Prometrium (progesterone USP) Capsules, Solvay Pharmaceuticals | PROMETRIUM (progesterone) Capsules, Unimed Pharma, Labeling Revision | PROMETRIUM (progesterone) Capsules, Unimed Pharma, Labeling Revision

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