Details for New Drug Application (NDA): 210148
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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.
Summary for 210148
Tradename: | BUSULFAN |
Applicant: | Accord Hlthcare Inc |
Ingredient: | busulfan |
Patents: | 0 |
Pharmacology for NDA: 210148
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 210148
Suppliers and Packaging for NDA: 210148
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSULFAN | busulfan | INJECTABLE;INJECTION | 210148 | ANDA | Accord Healthcare, Inc | 16729-351 | 16729-351-92 | 8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Feb 22, 2019 | TE: | AP | RLD: | No |
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