An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 063315
Company: HIKMA

Products on ANDA 063315

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 063315

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
03/21/2024	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/11/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/11/2016	SUPPL-15	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-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/08/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 063315

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

Top