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Last Updated: January 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207514

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NDA 207514 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Xiromed, Apotex, and Barr Labs Inc, and is included in nine NDAs. It is available from five 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. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Suppliers and Packaging for NDA: 207514
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, CHEWABLE;ORAL 207514 ANDA Amneal Pharmaceuticals NY LLC 60219-1031 60219-1031-7 3 BLISTER PACK in 1 CARTON (60219-1031-7) > 1 KIT in 1 BLISTER PACK (60219-1031-6)
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 207514 ANDA Amneal Pharmaceuticals NY LLC 69238-1031 69238-1031-7 3 BLISTER PACK in 1 CARTON (69238-1031-7) > 1 KIT in 1 BLISTER PACK (69238-1031-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.02MG;1MG
Approval Date:Sep 11, 2017TE:ABRLD:No

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