Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020907

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ACTIVELLA (ESTRADIOL; NORETHINDRONE ACETATE)
1MG;0.5MG
Marketing Status: Prescription

Active Ingredient: ESTRADIOL; NORETHINDRONE ACETATE
Proprietary Name: ACTIVELLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG;0.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020907
Product Number: 001
Approval Date: Nov 18, 1998
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACTIVELLA (ESTRADIOL; NORETHINDRONE ACETATE)
0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ESTRADIOL; NORETHINDRONE ACETATE
Proprietary Name: ACTIVELLA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020907
Product Number: 002
Approval Date: Dec 28, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information