Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064052
Company: BAUSCH AND LOMB
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
11/29/1993 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
11/27/2001 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/05/2000 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/15/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/03/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/2000 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/18/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/07/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/19/1998 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/13/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/21/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/26/1996 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/13/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/26/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/26/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/10/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/10/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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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