Details for New Drug Application (NDA): 208536
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NDA 208536 describes BUSULFAN, which is a drug marketed by Accord Hlthcare Inc, Actavis, Am Regent, Amneal, Apotex, Arthur Grp, Hospira, Meitheal, Mylan Institutional, Mylan Labs Ltd, Nexus, Pharmascience Inc, and Shilpa, and is included in thirteen 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.
Summary for 208536
| Tradename: | BUSULFAN |
| Applicant: | Mylan Institutional |
| Ingredient: | busulfan |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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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