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Details for New Drug Application (NDA): 079193

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NDA 079193 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Breckenridge Pharm, Teva Pharms Usa, and Barr, and is included in three NDAs. It is available from three 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 NDA: 079193

Tradename:
ESTRADIOL AND NORETHINDRONE ACETATE
Applicant:
Barr
Ingredient:
estradiol; norethindrone acetate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 079193

Suppliers and Packaging for NDA: 079193

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL 079193 ANDA Teva Pharmaceuticals USA, Inc. 0093-5455 0093-5455-28 1 BLISTER PACK in 1 CARTON (0093-5455-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL 079193 ANDA Teva Pharmaceuticals USA, Inc. 0093-5455 0093-5455-42 5 BLISTER PACK in 1 CARTON (0093-5455-42) > 28 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:May 11, 2010TE:ABRLD:No


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