Product Details for NDA 011839
PROVERA (MEDROXYPROGESTERONE ACETATE)
2.5MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
2.5MG
Marketing Status: Prescription
Active Ingredient: MEDROXYPROGESTERONE ACETATE
Proprietary Name: PROVERA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011839
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
PROVERA (MEDROXYPROGESTERONE ACETATE)
Proprietary Name: PROVERA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011839
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: MEDROXYPROGESTERONE ACETATE
Proprietary Name: PROVERA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011839
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
PROVERA (MEDROXYPROGESTERONE ACETATE)
Proprietary Name: PROVERA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N011839
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: MEDROXYPROGESTERONE ACETATE
Proprietary Name: PROVERA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N011839
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PROVERA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N011839
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information