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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078324


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NDA 078324 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, and Teva Pharms Usa, and is included in six NDAs. It is available from four 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 078324
Pharmacology for NDA: 078324
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 078324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324 ANDA Breckenridge Pharmaceutical, Inc. 51991-474 51991-474-28 1 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324 ANDA Breckenridge Pharmaceutical, Inc. 51991-623 51991-623-28 1 BLISTER PACK in 1 CARTON (51991-623-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Apr 17, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Jun 9, 2011TE:ABRLD:No

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