Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062612
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML 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
02/20/1986 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
03/24/2004 SUPPL-16 Labeling

Label is not available on this site.

03/06/2003 SUPPL-15 Labeling

Label is not available on this site.

04/09/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1998 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/25/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/14/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/04/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/28/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/20/1991 SUPPL-4 Labeling

Label is not available on this site.

GENTAMICIN SULFATE

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062366 FRESENIUS KABI USA
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062420 HOSPIRA
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062612 HOSPIRA

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