Details for New Drug Application (NDA): 091332

NDA 091332 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 Ltd, and is included in seven NDAs. It is available from five 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. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for 091332

Tradename:	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Applicant:	Lupin Ltd
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

Suppliers and Packaging for NDA: 091332

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;ORAL	091332	ANDA	Lupin Pharmaceuticals, Inc.	68180-873	68180-873-73	3 POUCH in 1 CARTON (68180-873-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, CHEWABLE in 1 BLISTER PACK (68180-832-74) * 7 TABLET in 1 BLISTER PACK (68180-856-74)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.035MG;0.4MG
Approval Date:	Mar 23, 2016	TE:	AB	RLD:	No

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