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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202742

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NDA 202742 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Barr Labs Inc, Mylan Labs Ltd, and Amneal Pharms, and is included in three NDAs. It is available from three 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-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 202742

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

Suppliers and Packaging for NDA: 202742

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 202742 ANDA Mylan Pharmaceuticals Inc. 0378-7301 0378-7301-53 3 POUCH in 1 POUCH (0378-7301-53) > 1 BLISTER PACK in 1 POUCH (0378-7301-85) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;1MG
Approval Date:Oct 30, 2014TE:ABRLD:No


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