Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021443

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ENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B)
0.3MG
Marketing Status: Discontinued

Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC B
Proprietary Name: ENJUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021443
Product Number: 001
Approval Date: Dec 20, 2004
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B)
0.45MG
Marketing Status: Discontinued

Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC B
Proprietary Name: ENJUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.45MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021443
Product Number: 002
Approval Date: Dec 20, 2004
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B)
0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC B
Proprietary Name: ENJUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021443
Product Number: 003
Approval Date: May 10, 2004
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B)
0.9MG
Marketing Status: Discontinued

Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC B
Proprietary Name: ENJUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.9MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021443
Product Number: 005
Approval Date: Apr 27, 2007
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B)
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC B
Proprietary Name: ENJUVIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021443
Product Number: 004
Approval Date: May 10, 2004
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information