Polymyxin B - POLYMYXIN B SULFATE
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Field |
Value |
NDC Code: |
63323-321 |
Proprietary Name: |
Polymyxin B |
Suffix: |
|
Non-Proprietary Name: |
POLYMYXIN B SULFATE |
Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Method: |
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
Original Marketing Date: |
17-11-2009 |
Category Name: |
ANDA |
Application Number: |
ANDA065372 |
Labeler: |
APP PHARMACEUTICALS, LLC |
Substance Name: |
POLYMYXIN B SULFATE |
Active Numerator Strength: |
500000 |
Active Ingredient Unit: |
[iU]/1 |
Pharm Classes: |
Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] |
DEA Schedule: |
|