Details for New Drug Application (NDA): 201528
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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 201528
Tradename: | TEMOZOLOMIDE |
Applicant: | Accord Hlthcare |
Ingredient: | temozolomide |
Patents: | 0 |
Pharmacology for NDA: 201528
Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 201528
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 201528 | ANDA | Accord Healthcare Inc. | 16729-048 | 16729-048-53 | 1 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASS |
TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 201528 | ANDA | Accord Healthcare Inc. | 16729-048 | 16729-048-54 | 1 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Feb 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 27, 2017 | TE: | AB | RLD: | No |
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