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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 203872

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NDA 203872 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 203872

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.03MG,0.01MG;0.15MG,N/A
Approval Date:	Dec 22, 2015	TE:	AB	RLD:	No

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