Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021065

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FEMHRT (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE)
0.0025MG;0.5MG
Marketing Status: Discontinued

Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Proprietary Name: FEMHRT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.0025MG;0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021065
Product Number: 001
Approval Date: Jan 14, 2005
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

FEMHRT (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE)
0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Proprietary Name: FEMHRT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021065
Product Number: 002
Approval Date: Oct 15, 1999
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information