Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205685
Company: XELLIA PHARMS APS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/16/2014 ORIG-1 Approval STANDARD

Label is not available on this site.

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 1.2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 050789 FRESENIUS KABI USA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065013 X GEN PHARMS
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205685 XELLIA PHARMS APS

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