Details for New Drug Application (NDA): 020954
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The generic ingredient in BUSULFEX 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 020954
Tradename: | BUSULFEX |
Applicant: | Otsuka Pharm |
Ingredient: | busulfan |
Patents: | 0 |
Pharmacology for NDA: 020954
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 020954
Suppliers and Packaging for NDA: 020954
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUSULFEX | busulfan | INJECTABLE;INJECTION | 020954 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-070 | 59148-070-91 | 8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Feb 4, 1999 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 020954
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka Pharm | BUSULFEX | busulfan | INJECTABLE;INJECTION | 020954-001 | Feb 4, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm | BUSULFEX | busulfan | INJECTABLE;INJECTION | 020954-001 | Feb 4, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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