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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 021029


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NDA 021029 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 021029
Tradename:TEMODAR
Applicant:Merck Sharp Dohme
Ingredient:temozolomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021029
Mechanism of ActionAlkylating 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 Corp. 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 Corp. 0085-1366 0085-1366-04 14 PACKET in 1 CARTON (0085-1366-04) > 1 CAPSULE in 1 PACKET (0085-1366-05)
Paragraph IV (Patent) Challenges for 021029
Tradename Dosage Ingredient NDA Submissiondate
TEMODAR CAPSULE;ORAL temozolomide 021029 2008-03-24
TEMODAR CAPSULE;ORAL temozolomide 021029 2007-03-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Aug 11, 1999TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Aug 11, 1999TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 11, 1999TE:ABRLD:Yes

Expired US Patents for NDA 021029

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-006 Oct 19, 2006   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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