Details for New Drug Application (NDA): 208536
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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 208536
Tradename: | BUSULFAN |
Applicant: | Mylan Institutional |
Ingredient: | busulfan |
Patents: | 0 |
Pharmacology for NDA: 208536
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 208536
Suppliers and Packaging for NDA: 208536
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSULFAN | busulfan | INJECTABLE;INJECTION | 208536 | ANDA | Mylan Institutional LLC | 67457-893 | 67457-893-08 | 8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Nov 20, 2017 | TE: | AP | RLD: | No |
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