Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050592
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRADEX DEXAMETHASONE; TOBRAMYCIN 0.1%;0.3% SUSPENSION/DROPS;OPHTHALMIC Prescription AB Yes 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
08/18/1988 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2003 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50592slr032_tobradex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50592slr032ltr.pdf
12/11/2002 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/2002 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/16/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/20/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-17 Labeling

Label is not available on this site.

09/09/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/31/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1996 SUPPL-14 Labeling

Label is not available on this site.

09/27/1996 SUPPL-13 Labeling

Label is not available on this site.

09/27/1996 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1994 SUPPL-7 Labeling

Label is not available on this site.

12/31/1991 SUPPL-6 Labeling

Label is not available on this site.

12/31/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/23/2003 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50592slr032_tobradex_lbl.pdf

TOBRADEX

SUSPENSION/DROPS;OPHTHALMIC; 0.1%;0.3%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOBRADEX DEXAMETHASONE; TOBRAMYCIN 0.1%;0.3% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 050592 NOVARTIS PHARMS CORP
TOBRAMYCIN AND DEXAMETHASONE DEXAMETHASONE; TOBRAMYCIN 0.1%;0.3% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 064134 BAUSCH AND LOMB

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