Details for New Drug Application (NDA): 210087
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The generic ingredient in FINZALA is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four 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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