Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062196
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
07/02/1980 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
12/23/2002 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/17/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/12/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/07/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/03/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/29/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/29/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/18/1998 SUPPL-5 Labeling

Label is not available on this site.

06/09/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/28/1995 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

GENTAMICIN SULFATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENOPTIC GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062452 ALLERGAN
GENTAK GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064163 AKORN
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062635 AKORN
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064048 BAUSCH AND LOMB
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 065121 PERRIGO CO TENNESSEE
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062196 SANDOZ INC

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