Details for New Drug Application (NDA): 209872
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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 209872
Tradename: | CYCLOPHOSPHAMIDE |
Applicant: | Anima |
Ingredient: | cyclophosphamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209872
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 209872
Suppliers and Packaging for NDA: 209872
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | cyclophosphamide | CAPSULE;ORAL | 209872 | ANDA | STI Pharma LLC | 54879-021 | 54879-021-01 | 100 CAPSULE in 1 BOTTLE (54879-021-01) |
CYCLOPHOSPHAMIDE | cyclophosphamide | CAPSULE;ORAL | 209872 | ANDA | STI Pharma LLC | 54879-022 | 54879-022-01 | 100 CAPSULE in 1 BOTTLE (54879-022-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | May 7, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | May 7, 2018 | TE: | AB | RLD: | No |
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