Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205604
Company: FRESENIUS KABI USA

Products on ANDA 205604

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205604

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/2015/205604Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/10/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/10/2023	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 205604

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	AVET LIFESCIENCES
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	064045	MEITHEAL
AMIKACIN SULFATE	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	218146	QILU
AMIKACIN SULFATE	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203323	SAGENT PHARMS INC