Details for New Drug Application (NDA): 204159
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The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 204159
Tradename: | TEMOZOLOMIDE |
Applicant: | Apotex |
Ingredient: | temozolomide |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 5, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Jul 5, 2018 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 5, 2018 | TE: | RLD: | No |
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