Details for New Drug Application (NDA): 207044

NDA 207044 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 207044

Tradename:	LEVONORGESTREL
Applicant:	Glenmark Pharms Ltd
Ingredient:	levonorgestrel
Patents:	0

Pharmacology for NDA: 207044

Physiological Effect

Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for 207044

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 207044

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVONORGESTREL	levonorgestrel	TABLET;ORAL	207044	ANDA	GLENMARK THERAPEUTICS INC., USA	72657-108	72657-108-11	1 BLISTER PACK in 1 CARTON (72657-108-11) / 1 TABLET in 1 BLISTER PACK
LEVONORGESTREL	levonorgestrel	TABLET;ORAL	207044	ANDA	GLENMARK THERAPEUTICS INC., USA	72657-108	72657-108-12	1 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Mar 25, 2016	TE:		RLD:	No

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