Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062356
Company: FRESENIUS KABI USA

Products on ANDA 062356

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062356

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/1982	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
09/11/2015	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
07/26/2013	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
03/09/2005	SUPPL-18	Labeling		Label is not available on this site.
05/03/2004	SUPPL-17	Labeling		Label is not available on this site.
03/07/2000	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/1993	SUPPL-14	Labeling		Label is not available on this site.
02/23/1995	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/06/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/07/2000	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/21/2000	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/18/1991	SUPPL-9	Labeling		Label is not available on this site.