Details for New Drug Application (NDA): 213418

NDA 213418 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apotex, Barr Labs Inc, and Xiromed, and is included in eleven 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 213418

Tradename:	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	ethinyl estradiol; norethindrone acetate
Patents:	0

Suppliers and Packaging for NDA: 213418

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	CAPSULE;ORAL	213418	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-849	68462-849-29	3 CARTON in 1 BOX (68462-849-29) / 1 BLISTER PACK in 1 CARTON (68462-849-84) / 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40) * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.02MG;1MG
Approval Date:	Jul 27, 2022	TE:	AB	RLD:	No

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