Details for New Drug Application (NDA): 205672
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The generic ingredient in BUSULFAN is busulfan. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Pharmacology for NDA: 205672
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 205672
Suppliers and Packaging for NDA: 205672
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSULFAN | busulfan | INJECTABLE;INJECTION | 205672 | ANDA | Hospira, Inc. | 0409-1112 | 0409-1112-01 | 8 CARTON in 1 CARTON (0409-1112-01) / 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Jul 31, 2018 | TE: | AP | RLD: | No |
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