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Generated: June 23, 2017

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 NDA: 022058

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022058

Mechanism of ActionGonadotropin Releasing Hormone Receptor Agonists

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 67979-002-01 1 VIAL, GLASS in 1 CARTON (67979-002-01) > 1 IMPLANT in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;SUBCUTANEOUSStrength50MG
Approval Date:May 3, 2007TE:RLD:Yes
Patent:8,062,652Patent Expiration:Jun 16, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY

Expired Orange Book Patents for NDA: 022058

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharm
SUPPRELIN LA
histrelin acetate
IMPLANT;SUBCUTANEOUS022058-001May 3, 20075,266,325► Subscribe
Endo Pharm
SUPPRELIN LA
histrelin acetate
IMPLANT;SUBCUTANEOUS022058-001May 3, 20075,292,515► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Healthtrust
Teva
Merck
Express Scripts
Deloitte
Dow
Johnson and Johnson
Baxter

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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