Details for New Drug Application (NDA): 019653
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NDA 019653 describes ORTHO CYCLEN-28, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ORTHO CYCLEN-28 profile page.
The generic ingredient in ORTHO CYCLEN-28 is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
The generic ingredient in ORTHO CYCLEN-28 is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 019653
| Tradename: | ORTHO CYCLEN-28 |
| Applicant: | Janssen Pharms |
| Ingredient: | ethinyl estradiol; norgestimate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 29, 1989 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 29, 1989 | TE: | RLD: | Yes | |||||
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