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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202766
Company: XELLIA PHARMS APS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/15/2014 ORIG-1 Approval

Label is not available on this site.

POLYMYXIN B SULFATE

INJECTABLE;INJECTION; EQ 500,000 UNITS BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206589 EUGIA PHARMA
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065372 FRESENIUS KABI USA
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207322 GLAND
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202766 XELLIA PHARMS APS
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Prescription No AP 063000 XGEN PHARMS
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