Product Details for NDA 019697
ORTHO TRI-CYCLEN (ETHINYL ESTRADIOL; NORGESTIMATE)
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; NORGESTIMATE
Proprietary Name: ORTHO TRI-CYCLEN
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019697
Product Number: 002
Approval Date: Jul 3, 1992
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ORTHO TRI-CYCLEN (ETHINYL ESTRADIOL; NORGESTIMATE)
Proprietary Name: ORTHO TRI-CYCLEN
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019697
Product Number: 002
Approval Date: Jul 3, 1992
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; NORGESTIMATE
Proprietary Name: ORTHO TRI-CYCLEN
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019697
Product Number: 001
Approval Date: Jul 3, 1992
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ORTHO TRI-CYCLEN
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **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: N019697
Product Number: 001
Approval Date: Jul 3, 1992
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information