Product Details for NDA 020992
CENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A)
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC A
Proprietary Name: CENESTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020992
Product Number: 001
Approval Date: Jun 21, 2002
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A)
Proprietary Name: CENESTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020992
Product Number: 001
Approval Date: Jun 21, 2002
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC A
Proprietary Name: CENESTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020992
Product Number: 005
Approval Date: Feb 5, 2004
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A)
Proprietary Name: CENESTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.45MG **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: N020992
Product Number: 005
Approval Date: Feb 5, 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 A
Proprietary Name: CENESTIN
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: Yes
Reference Standard: No
TE Code:
Application Number: N020992
Product Number: 002
Approval Date: Mar 24, 1999
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A)
Proprietary Name: CENESTIN
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: Yes
Reference Standard: No
TE Code:
Application Number: N020992
Product Number: 002
Approval Date: Mar 24, 1999
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESTROGENS, CONJUGATED SYNTHETIC A
Proprietary Name: CENESTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.9MG **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: N020992
Product Number: 003
Approval Date: Mar 24, 1999
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A)
Proprietary Name: CENESTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.9MG **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: N020992
Product Number: 003
Approval Date: Mar 24, 1999
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 A
Proprietary Name: CENESTIN
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: Yes
Reference Standard: No
TE Code:
Application Number: N020992
Product Number: 004
Approval Date: Mar 13, 2000
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CENESTIN
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: Yes
Reference Standard: No
TE Code:
Application Number: N020992
Product Number: 004
Approval Date: Mar 13, 2000
Applicant Holder Full Name: ASPEN PHARMA USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information