Details for New Drug Application (NDA): 040745
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The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 040745
Tradename: | CYCLOPHOSPHAMIDE |
Applicant: | Baxter Hlthcare |
Ingredient: | cyclophosphamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040745
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 040745
Suppliers and Packaging for NDA: 040745
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 040745 | ANDA | Baxter Healthcare Corporation | 10019-935 | 10019-935-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-935-01) / 25 mL in 1 VIAL, SINGLE-DOSE (10019-935-25) |
CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 040745 | ANDA | Baxter Healthcare Corporation | 10019-936 | 10019-936-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-936-01) / 50 mL in 1 VIAL, SINGLE-DOSE (10019-936-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | May 21, 2008 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
Approval Date: | May 21, 2008 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
Approval Date: | May 21, 2008 | TE: | AP | RLD: | No |
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