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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062420
Company: HOSPIRA

Products on ANDA 062420

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062420

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/1983	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-31	Labeling-Package Insert		Label is not available on this site.
02/01/2023	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
04/21/2004	SUPPL-14	Labeling		Label is not available on this site.
10/25/2002	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/22/2001	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/22/2001	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/07/2000	SUPPL-10	Labeling		Label is not available on this site.
01/07/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/18/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/22/1996	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/04/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/13/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062420

GENTAMICIN SULFATE

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

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

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