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Serving leading biopharmaceutical companies globally:

US Department of Justice
Federal Trade Commission
Johnson and Johnson
Boehringer Ingelheim
Fish and Richardson
US Army
Chinese Patent Office

Generated: December 15, 2017

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. Twenty-eight 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 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

Summary 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 leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Argus Health
US Department of Justice
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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