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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064045
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIKACIN SULFATE AMIKACIN SULFATE EQ 50MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
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
09/28/1993 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
05/29/2015 SUPPL-25 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/20/2013 SUPPL-24 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/17/2012 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/03/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/02/1995 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

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 063315 HIKMA
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203323 SAGENT PHARMS INC
AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE;INJECTION Prescription No AP 064045 TEVA PHARMS USA
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