Details for New Drug Application (NDA): 075259
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NDA 075259 describes DACARBAZINE, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, and Meitheal, and is included in six NDAs. It is available from three suppliers. Additional details are available on the DACARBAZINE profile page.
The generic ingredient in DACARBAZINE is dacarbazine. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dacarbazine profile page.
The generic ingredient in DACARBAZINE is dacarbazine. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dacarbazine profile page.
Summary for 075259
| Tradename: | DACARBAZINE |
| Applicant: | Meitheal |
| Ingredient: | dacarbazine |
| Patents: | 0 |
Pharmacology for NDA: 075259
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 075259
Suppliers and Packaging for NDA: 075259
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DACARBAZINE | dacarbazine | INJECTABLE;INJECTION | 075259 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-174 | 71288-174-21 | 10 VIAL, SINGLE-USE in 1 CARTON (71288-174-21) / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Sep 22, 2000 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/VIAL | ||||
| Approval Date: | Aug 27, 1998 | TE: | AP | RLD: | No | ||||
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