Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062373
Company: BAXTER HLTHCARE
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 80MG BASE/100ML INJECTABLE;INJECTION Prescription AP 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 100MG BASE/100ML INJECTABLE;INJECTION Prescription AP No No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 120MG BASE/100ML INJECTABLE;INJECTION Prescription None No Yes
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 1.6MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription None No Yes
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE EQ 2.4MG BASE/ML 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
09/07/1982 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
12/11/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

07/30/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-33 Labeling

Label is not available on this site.

11/05/2007 SUPPL-32 Labeling

Label is not available on this site.

08/31/2004 SUPPL-31 Labeling

Label is not available on this site.

12/29/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/21/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/17/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/28/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/25/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/17/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/04/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-19 Labeling

Label is not available on this site.

06/06/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/20/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/07/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/12/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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

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

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