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Generated: November 15, 2018

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Details for New Drug Application (NDA): 206229

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NDA 206229 describes LILETTA, which is a drug marketed by Medicines360 and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the LILETTA profile page.

The generic ingredient in LILETTA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 206229
Tradename:LILETTA
Applicant:Medicines360
Ingredient:levonorgestrel
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 206229
Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 206229
Suppliers and Packaging for NDA: 206229
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LILETTA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 206229 NDA Allergan, Inc. 0023-5858 0023-5858-01 1 TRAY in 1 CARTON (0023-5858-01) > 1 INTRAUTERINE DEVICE in 1 TRAY
LILETTA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 206229 NDA Actavis Pharma, Inc. 52544-035 52544-035-54 1 POUCH in 1 CARTON (52544-035-54) > 1 INTRAUTERINE DEVICE in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength52MG
Approval Date:Feb 26, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Feb 26, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Mar 22, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR PREVENTION OF PREGNANCY

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
McKinsey
Farmers Insurance
Daiichi Sankyo
Harvard Business School
Fish and Richardson
Citi
Accenture

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