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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062588
Company: HOSPIRA

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/06/1986 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
12/01/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
06/02/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
03/12/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
07/03/1996 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
08/07/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
04/24/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
03/10/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/02/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
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