Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064096
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKTOB TOBRAMYCIN 0.3% 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
01/31/1996 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
07/11/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/07/1999 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/05/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/19/1997 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/19/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AKTOB

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKTOB TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064096 AKORN
TOBRAMYCIN TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 064052 BAUSCH AND LOMB
TOBRAMYCIN TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 065026 FERA PHARMS
TOBRAMYCIN TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 207444 SOMERSET THERAPS LLC
TOBREX TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 050541 NOVARTIS PHARMS CORP
TOBREX TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062535 SANDOZ INC

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