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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062414
Company: HOSPIRA

Products on ANDA 062414

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.4MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.8MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 70MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 90MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062414

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-58	Labeling-Package Insert		Label is not available on this site.
06/23/2016	SUPPL-54	Labeling-Package Insert		Label is not available on this site.
04/19/2004	SUPPL-32	Labeling		Label is not available on this site.
11/01/2002	SUPPL-31	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/01/1998	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
09/18/1998	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
06/02/1997	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
04/08/1997	SUPPL-24	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/12/1996	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/03/1996	SUPPL-21	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/25/1994	SUPPL-19	Labeling		Label is not available on this site.
10/04/1993	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/28/1993	SUPPL-17	Labeling		Label is not available on this site.
03/10/1992	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/18/1991	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/02/1990	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/06/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/22/1990	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.

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