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Generated: June 24, 2019

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Details for New Drug Application (NDA): 207261

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NDA 207261 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs 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. Eight suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 207261
Pharmacology for NDA: 207261
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 207261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261 ANDA Mylan Pharmaceuticals Inc. 0378-7294 0378-7294-53 3 POUCH in 1 CARTON (0378-7294-53) > 1 BLISTER PACK in 1 POUCH (0378-7294-85) > 28 TABLET in 1 BLISTER PACK
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261 ANDA Mylan Pharmaceuticals Inc. 0378-7295 0378-7295-53 3 POUCH in 1 CARTON (0378-7295-53) > 1 BLISTER PACK in 1 POUCH (0378-7295-85) > 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Feb 10, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Feb 10, 2017TE:ABRLD:No

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