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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Fuji
McKesson
Medtronic
Queensland Health
Colorcon
US Army
Julphar
McKinsey

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022058

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NDA 022058 describes SUPPRELIN LA, which is a drug marketed by Endo Pharm and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SUPPRELIN LA profile page.

The generic ingredient in SUPPRELIN LA is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.
Summary for 022058
Tradename:SUPPRELIN LA
Applicant:Endo Pharm
Ingredient:histrelin acetate
Patents:1
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Pharmacology for NDA: 022058
Suppliers and Packaging for NDA: 022058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPPRELIN LA histrelin acetate IMPLANT;SUBCUTANEOUS 022058 NDA Endo Pharmaceuticals Solutions Inc. 67979-002 N 67979-002-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;SUBCUTANEOUSStrength50MG
Approval Date:May 3, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 16, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY

Expired US Patents for NDA 022058

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharm SUPPRELIN LA histrelin acetate IMPLANT;SUBCUTANEOUS 022058-001 May 3, 2007 ➤ Sign Up ➤ Sign Up
Endo Pharm SUPPRELIN LA histrelin acetate IMPLANT;SUBCUTANEOUS 022058-001 May 3, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Teva
McKinsey
Moodys
QuintilesIMS
UBS
Covington
Chinese Patent Office
Daiichi Sankyo

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