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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 two suppliers. Additional details are available on the GLIADEL profile page.

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

Summary for NDA: 020637

Tradename:
GLIADEL
Applicant:
Arbor Pharms Llc
Ingredient:
carmustine
Patents:0
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
GLIADEL
carmustine
IMPLANT;INTRACRANIAL 020637 NDA Eisai Inc. 62856-177 62856-177-08 8 POUCH in 1 BOX (62856-177-08) > 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

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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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