Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063313
Company: HIKMA

Products on ANDA 063313

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063313

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/1994	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
01/24/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/20/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/03/2001	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/04/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/23/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 063313

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	063313	HIKMA