Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021633

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FEMTRACE (ESTRADIOL ACETATE)
0.45MG
Marketing Status: Discontinued

Active Ingredient: ESTRADIOL ACETATE
Proprietary Name: FEMTRACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.45MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021633
Product Number: 001
Approval Date: Aug 20, 2004
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

FEMTRACE (ESTRADIOL ACETATE)
0.9MG
Marketing Status: Discontinued

Active Ingredient: ESTRADIOL ACETATE
Proprietary Name: FEMTRACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021633
Product Number: 002
Approval Date: Aug 20, 2004
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

FEMTRACE (ESTRADIOL ACETATE)
1.8MG
Marketing Status: Discontinued

Active Ingredient: ESTRADIOL ACETATE
Proprietary Name: FEMTRACE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021633
Product Number: 003
Approval Date: Aug 20, 2004
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information