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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 | Progesterone Injection, Watson Labs, Labeling Revision | Endometrin (progesterone) Vaginal Insert, Ferring Pharma, Approval | Endometrin (progesterone) Vaginal Insert, Ferring Pharma, Labeling Revision | Endometrin (progesterone) Vaginal Insert, Ferring Pharmaceuticals, Inc., Labeling Revision | Progesterone Injection, PharmaForce, Inc., Approval | Progesterone Injection, Hikma Farmaceutica, Approval | Prometrium (progesterone) Capsules, Abbott Products, Inc., Labeling Revision | Crinone (progesterone) Gel, Watson Laboratories, Inc., Labeling Revision | Crinone (progesterone) Gel, Watson Laboratories, Inc., Labeling Revision
  
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