Details for New Drug Application (NDA): 212127
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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: 212127
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 212127
Suppliers and Packaging for NDA: 212127
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSULFAN | busulfan | INJECTABLE;INJECTION | 212127 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-116 | 71288-116-11 | 8 VIAL, SINGLE-DOSE in 1 CARTON (71288-116-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10) |
BUSULFAN | busulfan | INJECTABLE;INJECTION | 212127 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-158 | 71288-158-96 | 8 VIAL, SINGLE-DOSE in 1 CARTON (71288-158-96) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-158-95) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Oct 23, 2020 | TE: | AP | RLD: | No |
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