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Last Updated: July 29, 2021

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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 two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. 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. Thirteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 022277
Applicant:Merck Sharp Dohme
Formulation / Manufacturing:see details
Pharmacology for NDA: 022277
Mechanism of ActionAlkylating 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 Corp. 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:RXDosage:POWDER;INTRAVENOUSStrength100MG/VIAL
Approval Date:Feb 27, 2009TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Sep 8, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Feb 21, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Feb 21, 2023Product Flag?YSubstance Flag?Delist Request?

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