Details for New Drug Application (NDA): 065177
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The generic ingredient in COLISTIMETHATE SODIUM is colistimethate sodium. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.
Summary for 065177
Tradename: | COLISTIMETHATE SODIUM |
Applicant: | Nexus |
Ingredient: | colistimethate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065177
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065177 | ANDA | Nexus Pharmaceuticals Inc | 14789-201 | 14789-201-05 | 10 VIAL in 1 CARTON (14789-201-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (14789-201-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 150MG BASE/VIAL | ||||
Approval Date: | Mar 19, 2004 | TE: | AP | RLD: | No |
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