Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203323
Company: SAGENT PHARMS INC

Products on ANDA 203323

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
AMIKACIN SULFATE	AMIKACIN SULFATE	500MG(BASE)/ML(250MG/ML)	INJECTABLE;INJECTION	Prescription	None	TBD	No
AMIKACIN SULFATE	AMIKACIN SULFATE	1G(BASE)/4ML(250MG/ML)	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/12/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2016	SUPPL-12	Manufacturing (CMC)-New Strength		Label is not available on this site.
02/10/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203323

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