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Last Updated: December 12, 2025

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 Teva Branded Pharm, Xiromed, Amneal Pharms, Barr, Lupin Ltd, and Naari Pte, and is included in seven NDAs. It is available from seven suppliers. 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. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 203371
Tradename:NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Applicant:Xiromed
Ingredient:ethinyl estradiol; norethindrone
Patents:0
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)
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203371 ANDA Xiromed, LLC 70700-306 70700-306-85 3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK

Profile 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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