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Drugs@FDA: FDA-Approved Drugs

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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TOBREX TOBRAMYCIN 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
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
05/14/2021 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050541s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050541Orig1s031ltr.pdf
04/24/2020 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050541s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050541Orig1s030ltr.pdf
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
05/14/2021 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050541s031lbl.pdf
04/24/2020 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050541s030lbl.pdf
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
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