Details for New Drug Application (NDA): 217651
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The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 217651
Tradename: | CYCLOPHOSPHAMIDE |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | cyclophosphamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217651
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 217651
Suppliers and Packaging for NDA: 217651
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 217651 | NDA | Nevakar Injectables Inc. | 82943-100 | 82943-100-03 | 1 VIAL in 1 CARTON (82943-100-03) / 2.5 mL in 1 VIAL |
CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 217651 | NDA | Nevakar Injectables Inc. | 82943-101 | 82943-101-05 | 1 VIAL in 1 CARTON (82943-101-05) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/2.5ML (200MG/ML) | ||||
Approval Date: | Jun 28, 2023 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/5ML (200MG/ML) | ||||
Approval Date: | Jun 28, 2023 | TE: | RLD: | Yes |
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