Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065026
Company: FERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN 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
09/11/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65026ltr.pdf

TOBRAMYCIN

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 211847 ALEMBIC PHARMS LTD
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
TOBREX TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 062535 SANDOZ INC

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