Product Details for NDA 020683
ALESSE (ETHINYL ESTRADIOL; LEVONORGESTREL)
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: ALESSE
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020683
Product Number: 001
Approval Date: Mar 27, 1997
Applicant Holder Full Name: CADENCE HEALTH
Marketing Status: Discontinued
Patent and Exclusivity Information
ALESSE (ETHINYL ESTRADIOL; LEVONORGESTREL)
Proprietary Name: ALESSE
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020683
Product Number: 001
Approval Date: Mar 27, 1997
Applicant Holder Full Name: CADENCE HEALTH
Marketing Status: Discontinued
Patent and Exclusivity Information
0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: ALESSE
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020683
Product Number: 002
Approval Date: Mar 27, 1997
Applicant Holder Full Name: CADENCE HEALTH
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ALESSE
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020683
Product Number: 002
Approval Date: Mar 27, 1997
Applicant Holder Full Name: CADENCE HEALTH
Marketing Status: Discontinued
Patent and Exclusivity Information