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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202508

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NDA 202508 describes LEVONORGESTREL, which is a drug marketed by Wyeth Pharms Inc, Alvogen, Annora Pharma, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, Barr, Amneal Pharms, Dr Reddys Labs Sa, and Hetero Labs, and is included in forty-seven NDAs. It is available from fifteen 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 202508

Tradename:	LEVONORGESTREL
Applicant:	Novel Labs Inc
Ingredient:	levonorgestrel
Patents:	0

Pharmacology for NDA: 202508

Physiological Effect	Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for 202508

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 202508

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202508	ANDA	Novel Laboratories, Inc.	40032-622	40032-622-30	1 TABLET in 1 CARTON (40032-622-30)
LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202508	ANDA	Lupin Pharmaceuticals,Inc.	43386-622	43386-622-30	1 TABLET in 1 CARTON (43386-622-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Feb 22, 2013	TE:		RLD:	No

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