Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050541
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBREX TOBRAMYCIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
12/12/1980 ORIG-1 Approval Type 3 - New Dosage Form 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
12/14/2012 SUPPL-24 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050541Orig1s024ltr.pdf
12/18/2012 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/04/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50541slr017_tobrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50541slr017ltr.pdf
02/18/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/04/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/05/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1994 SUPPL-2 Labeling

Label is not available on this site.

06/13/1995 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2012 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf
12/14/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf
07/22/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50541slr017_tobrex_lbl.pdf

TOBREX

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English