Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062814
Company: B BRAUN

Products on ANDA 062814

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 0.8MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
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 2.4MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 40MG BASE/100ML	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
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 120MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062814

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/1987	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
05/13/2010	SUPPL-21	Labeling-Container/Carton Labels		Label is not available on this site.
11/30/2009	SUPPL-18	Labeling		Label is not available on this site.
11/20/2008	SUPPL-17	Labeling		Label is not available on this site.
09/12/2007	SUPPL-16	Labeling		Label is not available on this site.
12/07/2006	SUPPL-15	Labeling		Label is not available on this site.
06/07/2005	SUPPL-13	Labeling		Label is not available on this site.
08/31/2004	SUPPL-12	Labeling		Label is not available on this site.
08/21/2001	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/03/2001	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/16/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/01/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/18/1992	SUPPL-5	Labeling		Label is not available on this site.
01/29/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.