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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202334


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NDA 202334 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, Mylan Labs Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, Amneal Pharms, Glenmark Generics, Barr, Dr Reddys Labs Sa, and Hetero Labs, and is included in forty-six NDAs. It is available from sixteen 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 202334
Tradename:LEVONORGESTREL
Applicant:Perrigo R And D
Ingredient:levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202334
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 202334
Suppliers and Packaging for NDA: 202334
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL levonorgestrel TABLET;ORAL 202334 ANDA L. Perrigo Company 0113-2003 0113-2003-12 1 BLISTER PACK in 1 CARTON (0113-2003-12) / 1 TABLET in 1 BLISTER PACK
LEVONORGESTREL levonorgestrel TABLET;ORAL 202334 ANDA Amazon.com Services LLC 72288-111 72288-111-12 1 BLISTER PACK in 1 CARTON (72288-111-12) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.5MG
Approval Date:Aug 20, 2014TE:RLD:No

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