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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078665


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NDA 078665 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 078665
Tradename:LEVONORGESTREL
Applicant:Fdn Consumer
Ingredient:levonorgestrel
Patents:0
Medical Subject Heading (MeSH) Categories for 078665

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 28, 2009TE:RLD:No

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