Details for New Drug Application (NDA): 202771

NDA 202771 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Glenmark Pharms Ltd, Xiromed, Dr Reddys Labs Sa, Amneal Pharms, and Apotex, and is included in twenty-three NDAs. It is available from four suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 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 202771

Tradename:	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Applicant:	Xiromed
Ingredient:	ethinyl estradiol; norethindrone acetate
Patents:	0

Pharmacology for NDA: 202771

Mechanism of Action

Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 202771

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	202771	ANDA	Mylan Pharmaceuticals Inc.	0378-7280	0378-7280-53	3 POUCH in 1 CARTON (0378-7280-53) / 1 BLISTER PACK in 1 POUCH (0378-7280-85) / 21 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-21			Strength	0.02MG;1MG
Approval Date:	Nov 6, 2013	TE:	AB	RLD:	No

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