Details for New Drug Application (NDA): 210931
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NDA 210931 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis, Am Regent, Amneal, Apotex, Arthur Grp, Eugia Pharma, Hospira, Meitheal, Mylan Institutional, Nexus, Norvium Bioscience, Pharmascience Inc, Prinston Inc, and Shilpa, and is included in fifteen NDAs. It is available from ten suppliers. Additional details are available on the BUSULFAN profile page.
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.
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: 210931
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 210931
Suppliers and Packaging for NDA: 210931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUSULFAN | busulfan | INJECTABLE;INJECTION | 210931 | ANDA | Armas Pharmaceuticals Inc. | 72485-210 | 72485-210-08 | 8 VIAL, SINGLE-DOSE in 1 CARTON (72485-210-08) / 10 mL in 1 VIAL, SINGLE-DOSE (72485-210-01) |
| BUSULFAN | busulfan | INJECTABLE;INJECTION | 210931 | ANDA | CELLTRION USA, INC. | 72606-559 | 72606-559-02 | 8 CARTON in 1 CARTON (72606-559-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON (72606-559-01) / 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: | Apr 18, 2019 | TE: | AP | RLD: | No | ||||
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