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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020527

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PREMPHASE 14/14 (ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE)
0.625MG,0.625MG;N/A,5MG
Marketing Status: Prescription
Active Ingredient: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Proprietary Name: PREMPHASE 14/14
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.625MG,0.625MG;N/A,5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020527
Product Number: 002
Approval Date: Nov 17, 1995
Applicant Holder Full Name: WYETH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PREMPRO (ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE)
0.3MG;1.5MG
Marketing Status: Prescription
Active Ingredient: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Proprietary Name: PREMPRO
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.3MG;1.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020527
Product Number: 005
Approval Date: Jun 4, 2003
Applicant Holder Full Name: WYETH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PREMPRO (ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE)
0.45MG;1.5MG
Marketing Status: Prescription
Active Ingredient: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Proprietary Name: PREMPRO
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.45MG;1.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020527
Product Number: 004
Approval Date: Mar 12, 2003
Applicant Holder Full Name: WYETH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PREMPRO (ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE)
0.625MG;2.5MG
Marketing Status: Prescription
Active Ingredient: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Proprietary Name: PREMPRO
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.625MG;2.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020527
Product Number: 001
Approval Date: Nov 17, 1995
Applicant Holder Full Name: WYETH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PREMPRO (ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE)
0.625MG;5MG
Marketing Status: Prescription
Active Ingredient: ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Proprietary Name: PREMPRO
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.625MG;5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020527
Product Number: 003
Approval Date: Jan 9, 1998
Applicant Holder Full Name: WYETH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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