Details for New Drug Application (NDA): 020637

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NDA 020637 describes GLIADEL, which is a drug marketed by Azurity 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. Twelve suppliers are listed for this compound. Additional details are available on the carmustine profile page.

Summary for 020637

Tradename:	GLIADEL
Applicant:	Azurity
Ingredient:	carmustine
Patents:	0

Pharmacology for NDA: 020637

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 020637

Antineoplastic Agents, Alkylating

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:	RX	Dosage:	IMPLANT;INTRACRANIAL			Strength	7.7MG
Approval Date:	Sep 23, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020637

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