Product Details for NDA 021443
ENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B)
0.3MG
Marketing Status: Discontinued
0.45MG
Marketing Status: Discontinued
0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.9MG
Marketing Status: Discontinued
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
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)
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
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)
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
0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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
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)
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
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
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