Details for New Drug Application (NDA): 020301
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The generic ingredient in ORTHO-CEPT is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 020301
Tradename: | ORTHO-CEPT |
Applicant: | Janssen Pharms |
Ingredient: | desogestrel; ethinyl estradiol |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 14, 1992 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 14, 1992 | TE: | RLD: | Yes |
Expired US Patents for NDA 020301
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | ORTHO-CEPT | desogestrel; ethinyl estradiol | TABLET;ORAL-21 | 020301-001 | Dec 14, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | ORTHO-CEPT | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 020301-002 | Dec 14, 1992 | ⤷ Sign Up | ⤷ Sign Up |
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