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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076221


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NDA 076221 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Glenmark Pharms Ltd, Xiromed, Dr Reddys Labs Sa, Amneal Pharms, and Apotex, and is included in twenty-three NDAs. It is available from four suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 076221
Pharmacology for NDA: 076221
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 076221
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 076221 ANDA Teva Pharmaceuticals USA, Inc. 0093-3122 0093-3122-42 5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28)
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 076221 ANDA Teva Pharmaceuticals USA, Inc. 0093-3122 0093-3122-98 90 TABLET in 1 BOTTLE (0093-3122-98)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.005MG;1MG
Approval Date:Nov 6, 2009TE:ABRLD:No

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