Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065121
Company: PERRIGO CO TENNESSEE
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
01/30/2004 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
07/11/2014 SUPPL-2 Labeling-Package Insert

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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