Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062414
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 Prescription AP 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 Prescription AP 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 Prescription AP 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 Prescription AP 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
08/15/1983 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
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.

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 1.2MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 1.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062373 BAXTER HLTHCARE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 1.2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062414 HOSPIRA

INJECTABLE;INJECTION; EQ 1.6MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 1.6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062373 BAXTER HLTHCARE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 1.6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062414 HOSPIRA

INJECTABLE;INJECTION; EQ 80MG BASE/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 80MG BASE/100ML INJECTABLE;INJECTION Prescription No AP 062373 BAXTER HLTHCARE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 80MG BASE/100ML INJECTABLE;INJECTION Prescription No AP 062414 HOSPIRA

INJECTABLE;INJECTION; EQ 100MG BASE/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 100MG BASE/100ML INJECTABLE;INJECTION Prescription No AP 062373 BAXTER HLTHCARE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 100MG BASE/100ML INJECTABLE;INJECTION Prescription No AP 062414 HOSPIRA

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