Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203323
Company: SAGENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
AMIKACIN SULFATE AMIKACIN SULFATE 500MG(BASE)/ML(250MG/ML) INJECTABLE;INJECTION Prescription None TBD No
AMIKACIN SULFATE AMIKACIN SULFATE 1G(BASE)/4ML(250MG/ML) INJECTABLE;INJECTION Prescription None TBD 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
05/12/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/12/2016 SUPPL-12 Manufacturing (CMC)-New Strength

Label is not available on this site.

AMIKACIN SULFATE

INJECTABLE;INJECTION; EQ 250MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204040 EMCURE PHARMS LTD
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 205604 FRESENIUS KABI USA
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203323 SAGENT PHARMS
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 064045 TEVA PHARMS USA
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063315 WEST-WARD PHARMS INT

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