Details for New Drug Application (NDA): 203691
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NDA 203691 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Ani Pharms, Apotex, Chartwell, Chartwell Molecular, Chemi Spa, Deva Holding As, Heritage, Hetero Labs Ltd V, Nivagen Pharms Inc, 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 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.
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 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 | AvPAK | 50268-761 | 50268-761-12 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-761-12) / 1 CAPSULE in 1 BLISTER PACK (50268-761-11) |
| TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 203691 | ANDA | AvPAK | 50268-762 | 50268-762-12 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-762-12) / 1 CAPSULE in 1 BLISTER PACK (50268-762-11) |
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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