Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063313
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIKACIN SULFATE AMIKACIN SULFATE EQ 50MG BASE/ML 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
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
11/20/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/03/2001 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/23/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMIKACIN SULFATE

INJECTABLE;INJECTION; EQ 50MG 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 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 205605 FRESENIUS KABI USA
AMIKACIN SULFATE AMIKACIN SULFATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063313 WEST-WARD PHARMS INT

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