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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090938

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NDA 090938 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Amneal Pharms, Mylan Labs Ltd, and Barr Labs Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 090938

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090938

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 090938 ANDA Teva Pharmaceuticals USA, Inc. 0093-5328 0093-5328-62 3 POUCH in 1 CARTON (0093-5328-62) > 1 BLISTER PACK in 1 POUCH (0093-5328-28) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;1MG
Approval Date:Dec 1, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
Johnson and Johnson
Fish and Richardson
McKesson
Farmers Insurance
Cerilliant
Federal Trade Commission
Moodys
Daiichi Sankyo
Argus Health

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