Details for New Drug Application (NDA): 204639
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The generic ingredient in TEMOZOLOMIDE 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 204639
Tradename: | TEMOZOLOMIDE |
Applicant: | Chemi Spa |
Ingredient: | temozolomide |
Patents: | 0 |
Pharmacology for NDA: 204639
Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 204639
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 204639 | ANDA | Areva Pharmaceuticals | 59923-703 | 59923-703-05 | 1 BOTTLE, GLASS in 1 CARTON (59923-703-05) / 5 CAPSULE in 1 BOTTLE, GLASS |
TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 204639 | ANDA | Areva Pharmaceuticals | 59923-704 | 59923-704-14 | 1 BOTTLE, GLASS in 1 CARTON (59923-704-14) / 14 CAPSULE in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 23, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 23, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 23, 2016 | TE: | AB | RLD: | No |
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