Details for New Drug Application (NDA): 202766
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The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.
Summary for 202766
Tradename: | POLYMYXIN B SULFATE |
Applicant: | Xellia Pharms Aps |
Ingredient: | polymyxin b sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 202766
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 202766 | ANDA | Fresenius Kabi USA, LLC | 63323-367 | 63323-367-44 | 10 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41) |
POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 202766 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-049 | 70594-049-01 | 1 VIAL, GLASS in 1 CARTON (70594-049-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500,000 UNITS BASE/VIAL | ||||
Approval Date: | Jan 15, 2014 | TE: | AP | RLD: | No |
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