Details for New Drug Application (NDA): 079218

NDA 079218 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Glenmark Pharms Ltd, Lupin Ltd, Naari Pte, Watson Labs, Xiromed, Barr, Amneal Pharms, Dr Reddys Labs Sa, and Hetero Labs, and is included in twenty-nine NDAs. It is available from eight suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 079218

Tradename:	LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:	Watson Labs
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	0

Pharmacology for NDA: 079218

Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Suppliers and Packaging for NDA: 079218

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	079218	ANDA	Teva Pharmaceuticals, Inc.	0480-3472	0480-3472-24	1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.02MG;0.09MG
Approval Date:	Jun 6, 2011	TE:	AB	RLD:	No

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