Details for New Drug Application (NDA): 215102
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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 215102
Tradename: | BUSULFAN |
Applicant: | Eugia Pharma |
Ingredient: | busulfan |
Patents: | 0 |
Pharmacology for NDA: 215102
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 215102
Suppliers and Packaging for NDA: 215102
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSULFAN | busulfan | INJECTABLE;INJECTION | 215102 | ANDA | Eugia US LLC | 55150-395 | 55150-395-08 | 8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Jun 25, 2024 | TE: | AP | RLD: | No |
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