Product Details for ANDA 206413
TEMOZOLOMIDE (TEMOZOLOMIDE)
5MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
140MG
Marketing Status: Prescription
180MG
Marketing Status: Prescription
250MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 001
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
TEMOZOLOMIDE (TEMOZOLOMIDE)
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 001
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 002
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
TEMOZOLOMIDE (TEMOZOLOMIDE)
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 002
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 003
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
TEMOZOLOMIDE (TEMOZOLOMIDE)
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 003
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
140MG
Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 140MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 004
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
TEMOZOLOMIDE (TEMOZOLOMIDE)
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 140MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 004
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
180MG
Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 005
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
TEMOZOLOMIDE (TEMOZOLOMIDE)
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 005
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
250MG
Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 006
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: TEMOZOLOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206413
Product Number: 006
Approval Date: Apr 12, 2016
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information