Details for New Drug Application (NDA): 217087
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NDA 217087 describes MINZOYA, which is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. Additional details are available on the MINZOYA profile page.
The generic ingredient in MINZOYA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in MINZOYA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 217087
| Tradename: | MINZOYA |
| Applicant: | Lupin |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINZOYA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 217087 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-322 | 70748-322-14 | 3 BLISTER PACK in 1 CARTON (70748-322-14) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;0.1MG | ||||
| Approval Date: | Feb 15, 2024 | TE: | AB3 | RLD: | No | ||||
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