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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Julphar
Medtronic
Deloitte
Baxter
Queensland Health
AstraZeneca
Daiichi Sankyo
McKesson
Covington

Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020637

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NDA 020637 describes GLIADEL, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the GLIADEL profile page.

The generic ingredient in GLIADEL is carmustine. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the carmustine profile page.

Summary for NDA: 020637

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020637

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 020637

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIADEL
carmustine
IMPLANT;INTRACRANIAL 020637 NDA Arbor Pharmaceuticals 24338-050 24338-050-08 8 POUCH in 1 BOX (24338-050-08) > 1 WAFER in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;INTRACRANIALStrength7.7MG
Approval Date:Sep 23, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020637

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
GLIADEL
carmustine
IMPLANT;INTRACRANIAL020637-001Sep 23, 19964,757,128► Subscribe
Arbor Pharms Llc
GLIADEL
carmustine
IMPLANT;INTRACRANIAL020637-001Sep 23, 19965,179,189► Subscribe
Arbor Pharms Llc
GLIADEL
carmustine
IMPLANT;INTRACRANIAL020637-001Sep 23, 19964,789,724► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Medtronic
Julphar
Citi
Federal Trade Commission
Accenture
Argus Health
Healthtrust
Covington
Novartis

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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