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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021029

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TEMODAR (TEMOZOLOMIDE)
5MG
Marketing Status: Discontinued
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021029
Product Number: 001
Approval Date: Aug 11, 1999
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
TEMODAR (TEMOZOLOMIDE)
20MG
Marketing Status: Discontinued
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021029
Product Number: 002
Approval Date: Aug 11, 1999
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
TEMODAR (TEMOZOLOMIDE)
100MG
Marketing Status: Discontinued
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021029
Product Number: 003
Approval Date: Aug 11, 1999
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
TEMODAR (TEMOZOLOMIDE)
140MG
Marketing Status: Discontinued
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 140MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021029
Product Number: 005
Approval Date: Oct 19, 2006
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
TEMODAR (TEMOZOLOMIDE)
180MG
Marketing Status: Discontinued
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021029
Product Number: 006
Approval Date: Oct 19, 2006
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
TEMODAR (TEMOZOLOMIDE)
250MG
Marketing Status: Discontinued
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021029
Product Number: 004
Approval Date: Aug 11, 1999
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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