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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062251
Company: HIKMA

Products on ANDA 062251

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062251

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1980	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
02/15/2022	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
07/23/2001	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
07/23/2001	SUPPL-27	Manufacturing (CMC)-Facility		Label is not available on this site.
07/23/2001	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
10/14/1999	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
02/11/1999	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/03/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/16/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/18/1991	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/17/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/31/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/08/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/19/1990	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/12/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/22/1987	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062251

GENTAMICIN SULFATE

INJECTABLE;INJECTION; EQ 40MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215237	EUGIA PHARMA
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062366	FRESENIUS KABI USA
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062251	HIKMA
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062420	HOSPIRA

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215236	EUGIA PHARMA
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062366	FRESENIUS KABI USA
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062251	HIKMA
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062420	HOSPIRA

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