Last Updated: November 8, 2026

Details for New Drug Application (NDA): 091663

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NDA 091663 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, Hetero Labs, and Lupin, and is included in twenty-nine NDAs. It is available from seven 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 is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 091663

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.03MG;0.15MG
Approval Date:	Dec 21, 2012	TE:	AB	RLD:	No

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