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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim

Generated: May 22, 2018

DrugPatentWatch Database Preview

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. 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
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 N 0023-5858-01
LILETTA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 206229 NDA Actavis Pharma, Inc. 52544-035 N 52544-035-54

Profile for product number 001

Approval Date:Feb 26, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Feb 26, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Farmers Insurance
Cantor Fitzgerald
Boehringer Ingelheim

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