Details for New Drug Application (NDA): 021029

✉ Email this page to a colleague

NDA 021029 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 021029

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

Pharmacology for NDA: 021029

Mechanism of Action	Alkylating Activity

Suppliers and Packaging for NDA: 021029

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1366	0085-1366-03	5 PACKET in 1 CARTON (0085-1366-03) / 1 CAPSULE in 1 PACKET (0085-1366-05)
TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1366	0085-1366-04	14 PACKET in 1 CARTON (0085-1366-04) / 1 CAPSULE in 1 PACKET (0085-1366-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Aug 11, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Aug 11, 1999	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Aug 11, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 021029

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-005	Oct 19, 2006	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-006	Oct 19, 2006	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-003	Aug 11, 1999	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-002	Aug 11, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.