Details for New Drug Application (NDA): 203691
NDA 203691 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 203691
| Tradename: | TEMOZOLOMIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | temozolomide |
| Patents: | 0 |
Pharmacology for NDA: 203691
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 203691
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203691 | ANDA | Amneal Pharmaceuticals LLC | 65162-801 | 65162-801-14 | 1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLE |
| TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203691 | ANDA | Amneal Pharmaceuticals LLC | 65162-801 | 65162-801-51 | 1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 8, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | May 8, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 8, 2015 | TE: | AB | RLD: | No | ||||
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