Details for New Drug Application (NDA): 016029
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NDA 016029 describes OVULEN-21, which is a drug marketed by Gd Searle Llc and is included in one NDA. Additional details are available on the OVULEN-21 profile page.
The generic ingredient in OVULEN-21 is ethynodiol diacetate; mestranol. There are four drug master file entries for this compound. Additional details are available on the ethynodiol diacetate; mestranol profile page.
The generic ingredient in OVULEN-21 is ethynodiol diacetate; mestranol. There are four drug master file entries for this compound. Additional details are available on the ethynodiol diacetate; mestranol profile page.
Summary for 016029
| Tradename: | OVULEN-21 |
| Applicant: | Gd Searle Llc |
| Ingredient: | ethynodiol diacetate; mestranol |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-20 | Strength | 1MG;0.1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 1MG;0.1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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