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Federal Trade Commission
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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203371

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NDA 203371 describes NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Lupin Ltd, Barr, Accord Hlthcare, Mylan Labs Ltd, Apil, and Amneal Pharms, and is included in seven NDAs. It is available from six suppliers. There is one patent protecting this drug. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

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

Summary for NDA: 203371

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

Suppliers and Packaging for NDA: 203371

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL 203371 ANDA Mylan Pharmaceuticals Inc. 0378-7308 0378-7308-53 3 POUCH in 1 CARTON (0378-7308-53) > 1 KIT in 1 POUCH (0378-7308-85)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.025MG;0.8MG
Approval Date:Apr 23, 2014TE:ABRLD:No


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