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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 204044

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NDA 204044 describes LEVONORGESTREL, which is a drug marketed by Wyeth Pharms Inc, Alvogen, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, Amneal Pharms, Barr, Dr Reddys Labs Sa, and Hetero Labs, and is included in forty-six NDAs. It is available from fourteen suppliers. Additional details are available on the LEVONORGESTREL profile page.

The generic ingredient in LEVONORGESTREL is ethinyl estradiol; levonorgestrel. 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; levonorgestrel profile page.

Summary for 204044

Tradename:	LEVONORGESTREL
Applicant:	Laboratoire Hra
Ingredient:	levonorgestrel
Patents:	0

Medical Subject Heading (MeSH) Categories for 204044

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Jul 3, 2018	TE:		RLD:	No

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