Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205605
Company: FRESENIUS KABI 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 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
12/09/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205605Orig1s000ltr.pdf

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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