Details for New Drug Application (NDA): 022277

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NDA 022277 describes TEMODAR, which is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from one supplier. Additional details are available on the TEMODAR profile page.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for 022277

Tradename:	TEMODAR
Applicant:	Merck Sharp Dohme
Ingredient:	temozolomide
Patents:	0

Pharmacology for NDA: 022277

Mechanism of Action	Alkylating Activity

Suppliers and Packaging for NDA: 022277

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277	NDA	Merck Sharp & Dohme LLC	0085-1381	0085-1381-01	1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Feb 27, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022277

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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