Drugs@FDA: FDA Approved Drug Products

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

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