Details for New Drug Application (NDA): 020683
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NDA 020683 describes ALESSE, which is a drug marketed by Cadence Health and is included in one NDA. Additional details are available on the ALESSE profile page.
The generic ingredient in ALESSE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in ALESSE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 020683
| Tradename: | ALESSE |
| Applicant: | Cadence Health |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 27, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 27, 1997 | TE: | RLD: | Yes | |||||
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