Details for New Drug Application (NDA): 211757
✉ Email this page to a colleague
The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 211757
Tradename: | CYCLOPHOSPHAMIDE |
Applicant: | Xgen Pharms |
Ingredient: | cyclophosphamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 211757
Suppliers and Packaging for NDA: 211757
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 211757 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0250 | 39822-0250-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-0250-1) / 25 mL in 1 VIAL, SINGLE-DOSE |
CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 211757 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0255 | 39822-0255-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-0255-1) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Oct 18, 2022 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
Approval Date: | Oct 18, 2022 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
Approval Date: | Oct 18, 2022 | TE: | AP | RLD: | No |
Complete Access Available with Subscription