Details for New Drug Application (NDA): 072723
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NDA 072723 describes ZOVIA 1/50E-28, which is a drug marketed by Watson Labs and is included in one NDA. It is available from one supplier. Additional details are available on the ZOVIA 1/50E-28 profile page.
The generic ingredient in ZOVIA 1/50E-28 is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
The generic ingredient in ZOVIA 1/50E-28 is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
Summary for 072723
| Tradename: | ZOVIA 1/50E-28 |
| Applicant: | Watson Labs |
| Ingredient: | ethinyl estradiol; ethynodiol diacetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 072723
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOVIA 1/50E-28 | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 072723 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8073 | 0093-8073-16 | 6 BLISTER PACK in 1 CARTON (0093-8073-16) / 1 KIT in 1 BLISTER PACK (0093-8073-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.05MG;1MG | ||||
| Approval Date: | Dec 30, 1991 | TE: | AB | RLD: | No | ||||
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