Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019004

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ORTHO-NOVUM 7/14-21 (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0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: ORTHO-NOVUM 7/14-21
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Strength: 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: No
Reference Standard: No
TE Code: 
Application Number: N019004
Product Number: 001
Approval Date: Apr 4, 1984
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ORTHO-NOVUM 7/14-28 (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0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: ORTHO-NOVUM 7/14-28
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: No
Reference Standard: No
TE Code: 
Application Number: N019004
Product Number: 002
Approval Date: Apr 4, 1984
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information