Details for New Drug Application (NDA): 210087
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NDA 210087 describes FINZALA, which is a drug marketed by Teva Pharms Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the FINZALA profile page.
The generic ingredient in FINZALA is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in FINZALA is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 210087
| Tradename: | FINZALA |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FINZALA | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 210087 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8210 | 0093-8210-62 | 3 POUCH in 1 CARTON (0093-8210-62) / 1 BLISTER PACK in 1 POUCH (0093-8210-28) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (0093-3476-38) * 4 TABLET in 1 BLISTER PACK (0093-3525-44) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;1MG | ||||
| Approval Date: | Apr 7, 2020 | TE: | AB | RLD: | No | ||||
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