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Details for New Drug Application (NDA): 017489
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The generic ingredient in ORTHO-NOVUM 1/35-21 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 017489
Tradename: | ORTHO-NOVUM 1/35-21 |
Applicant: | Ortho Mcneil Pharm |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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