Details for New Drug Application (NDA): 207322
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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 207322
Tradename: | POLYMYXIN B SULFATE |
Applicant: | Gland |
Ingredient: | polymyxin b sulfate |
Patents: | 0 |
Suppliers and Packaging for NDA: 207322
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 207322 | ANDA | Gland Pharma Limited | 68083-174 | 68083-174-10 | 10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01) |
POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 207322 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-103 | 70860-103-10 | 10 VIAL in 1 CARTON (70860-103-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70860-103-41) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500,000 UNITS BASE/VIAL | ||||
Approval Date: | Apr 14, 2016 | TE: | AP | RLD: | No |
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