Details for New Drug Application (NDA): 206309
NDA 206309 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Ani Pharms, Apotex, Chartwell, Chemi Spa, Deva Holding As, Eirgen, Heritage, Hetero Labs Ltd V, Nivagen, Pharmazone, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the TEMOZOLOMIDE profile page.
The generic ingredient in TEMOZOLOMIDE is temozolomide. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
The generic ingredient in TEMOZOLOMIDE is temozolomide. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 206309
| Tradename: | TEMOZOLOMIDE |
| Applicant: | Rising |
| Ingredient: | temozolomide |
| Patents: | 0 |
Pharmacology for NDA: 206309
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 206309
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 206309 | ANDA | Rising Pharma Holdings, Inc. | 16571-816 | 16571-816-02 | 20 CAPSULE in 1 BOTTLE (16571-816-02) |
| TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 206309 | ANDA | Rising Pharma Holdings, Inc. | 16571-816 | 16571-816-41 | 14 CAPSULE in 1 BOTTLE (16571-816-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 27, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 27, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 27, 2016 | TE: | AB | RLD: | No | ||||
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