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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210612


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NDA 210612 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, and Xiromed, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ESTRADIOL AND NORETHINDRONE ACETATE profile page.

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
Pharmacology for NDA: 210612
Mechanism of ActionEstrogen 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:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Apr 3, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Apr 3, 2019TE:ABRLD:No

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