Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063315
Company: WEST-WARD PHARMS INT
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/11/1994 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/11/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

11/20/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/03/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/08/1997 SUPPL-1 Manufacturing (CMC)

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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