Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064045
Company: MEITHEAL

Products on ANDA 064045

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064045

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
02/10/2023	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
01/24/2023	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
01/24/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
05/29/2015	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 064045

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