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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 three 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. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Aug 11, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Aug 11, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 11, 1999TE:ABRLD:No

Expired Orange Book Patents for NDA: 021029

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 19995,260,291*PED► subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-006Oct 19, 20065,260,291*PED► subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 20065,260,291*PED► subscribe
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