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Generated: November 20, 2018

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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 one supplier. Additional details are available on the GLIADEL profile page.

The generic ingredient in GLIADEL is carmustine. There are eleven 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 020637
Tradename:GLIADEL
Applicant:Arbor Pharms Llc
Ingredient:carmustine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020637
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 020637
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

Profile for product number 001

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

Expired US Patents for NDA 020637

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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