Details for New Drug Application (NDA): 204639

NDA 204639 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Ani Pharms, Apotex, Chartwell, Chartwell Molecular, Chemi Spa, Deva Holding As, Heritage, Hetero Labs Ltd V, Nivagen Pharms Inc, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the TEMOZOLOMIDE profile page.

The generic ingredient in TEMOZOLOMIDE 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 204639

Tradename:	TEMOZOLOMIDE
Applicant:	Chemi Spa
Ingredient:	temozolomide
Patents:	0

Pharmacology for NDA: 204639

Mechanism of Action

Alkylating Activity

Suppliers and Packaging for NDA: 204639

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	204639	ANDA	Areva Pharmaceuticals	59923-703	59923-703-05	1 BOTTLE, GLASS in 1 CARTON (59923-703-05) / 5 CAPSULE in 1 BOTTLE, GLASS
TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	204639	ANDA	Areva Pharmaceuticals	59923-704	59923-704-14	1 BOTTLE, GLASS in 1 CARTON (59923-704-14) / 14 CAPSULE in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Nov 23, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Nov 23, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Nov 23, 2016	TE:	AB	RLD:	No

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