Details for New Drug Application (NDA): 205329

NDA 205329 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 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-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 205329

Tradename:	LEVONORGESTREL
Applicant:	Xiromed
Ingredient:	levonorgestrel
Patents:	0

Pharmacology for NDA: 205329

Physiological Effect

Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for 205329

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 205329

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVONORGESTREL	levonorgestrel	TABLET;ORAL	205329	ANDA	P & L Development, LLC	59726-138	59726-138-01	1 BLISTER PACK in 1 CARTON (59726-138-01) / 1 TABLET in 1 BLISTER PACK
LEVONORGESTREL	levonorgestrel	TABLET;ORAL	205329	ANDA	Rapha Pharmaceuticals, Inc.	69953-516	69953-516-01	1 BLISTER PACK in 1 CARTON (69953-516-01) / 1 mg in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Sep 18, 2018	TE:		RLD:	No

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