Details for New Drug Application (NDA): 063000
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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 063000
Tradename: | POLYMYXIN B SULFATE |
Applicant: | Beowulf Asset |
Ingredient: | polymyxin b sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 063000
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 063000 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0166 | 39822-0166-5 | 1 VIAL in 1 CARTON (39822-0166-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 063000 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-0166 | 39822-0166-7 | 1 VIAL in 1 CARTON (39822-0166-7) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500,000 UNITS BASE/VIAL | ||||
Approval Date: | Sep 30, 1994 | TE: | AP | RLD: | No |
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