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Generated: November 25, 2017

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Details for New Drug Application (NDA): 203691

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NDA 203691 describes TEMOZOLOMIDE, which is a drug marketed by Rising Pharms Inc, Idt Australia Ltd, Mylan Pharms Inc, Accord Hlthcare, Chemi Spa, Sun Pharma Global, Zydus Pharms Usa Inc, Deva Holding As, Watson Labs Teva, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in thirteen NDAs. It is available from fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for 203691

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203691

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 203691

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL 203691 ANDA AvPAK 50268-761 50268-761-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-761-12) > 1 CAPSULE in 1 BLISTER PACK (50268-761-11)
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL 203691 ANDA AvPAK 50268-762 50268-762-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-762-12) > 1 CAPSULE in 1 BLISTER PACK (50268-762-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:May 8, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:May 8, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 8, 2015TE:ABRLD:No


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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 verifification 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.

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