Product Details for NDA 018354
ORTHO-NOVUM 10/11-21 (ETHINYL ESTRADIOL; NORETHINDRONE)
0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.035MG,0.035MG;0.5MG,1MG
Marketing Status: Discontinued
0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: ORTHO-NOVUM 10/11-21
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018354
Product Number: 001
Approval Date: Jan 11, 1982
Applicant Holder Full Name: ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ORTHO-NOVUM 10/11-28 (ETHINYL ESTRADIOL; NORETHINDRONE)
Proprietary Name: ORTHO-NOVUM 10/11-21
Dosage Form; Route of Administration: TABLET; ORAL-21
Strength: 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018354
Product Number: 001
Approval Date: Jan 11, 1982
Applicant Holder Full Name: ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.035MG,0.035MG;0.5MG,1MG
Marketing Status: Discontinued
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: ORTHO-NOVUM 10/11-28
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG,0.035MG;0.5MG,1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018354
Product Number: 002
Approval Date: Jan 11, 1982
Applicant Holder Full Name: ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ORTHO-NOVUM 10/11-28
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG,0.035MG;0.5MG,1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018354
Product Number: 002
Approval Date: Jan 11, 1982
Applicant Holder Full Name: ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information