Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064093
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT;OPHTHALMIC Prescription AT No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/1995 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
03/10/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/27/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 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

OINTMENT;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT;OPHTHALMIC Prescription No AT 064093 AKORN
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT;OPHTHALMIC Prescription No AT 065024 PERRIGO CO TENNESSEE

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