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Generated: September 21, 2018

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Details for New Drug Application (NDA): 078665

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NDA 078665 describes LEVONORGESTREL, which is a drug marketed by Wyeth Pharms Inc, Fdn Consumer, Glenmark Pharms Ltd, Haupt Pharma, Lotus Pharm Co Ltd, Lupin Ltd, Mylan Labs Ltd, Novel Labs Inc, Oc Pharma, Perrigo R And D, Reckitt Benckiser, Watson Labs, Amneal Pharms, Glenmark Generics, Barr, Mayne Pharma, and Labs Leon Farma, and is included in forty 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-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
Formulation / Manufacturing:see details
Pharmacology for NDA: 078665
Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 078665
Suppliers and Packaging for NDA: 078665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL levonorgestrel TABLET;ORAL 078665 ANDA H.J. Harkins Company, Inc. 52959-450 52959-450-02 2 TABLET in 1 BLISTER PACK (52959-450-02)
LEVONORGESTREL levonorgestrel TABLET;ORAL 078665 ANDA Dispensing Solutions, Inc. 68258-3029 68258-3029-1 1 BLISTER PACK in 1 CARTON (68258-3029-1) > 2 TABLET in 1 BLISTER PACK

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 28, 2009TE:RLD:No

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