Details for New Drug Application (NDA): 210612
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The generic ingredient in ESTRADIOL AND NORETHINDRONE ACETATE is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 210612
Tradename: | ESTRADIOL AND NORETHINDRONE ACETATE |
Applicant: | Novast Labs |
Ingredient: | estradiol; norethindrone acetate |
Patents: | 0 |
Pharmacology for NDA: 210612
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 210612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 210612 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-657 | 50742-657-28 | 1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK (50742-657-01) |
ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 210612 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-657 | 50742-657-68 | 6 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK (50742-657-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG;0.1MG | ||||
Approval Date: | Apr 3, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG;0.5MG | ||||
Approval Date: | Apr 3, 2019 | TE: | AB | RLD: | No |
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