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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 205329


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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 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 205329
Tradename:LEVONORGESTREL
Applicant:Xiromed
Ingredient:levonorgestrel
Patents:0
Pharmacology for NDA: 205329
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 205329
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:OTCDosage:TABLET;ORALStrength1.5MG
Approval Date:Sep 18, 2018TE:RLD:No

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