Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050555
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBREX | TOBRAMYCIN | 0.3% | OINTMENT;OPHTHALMIC | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/25/1981 | 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-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050555s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050555Orig1s038ltr.pdf | |
| 04/24/2020 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050555s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050555Orig1s037ltr.pdf | |
| 09/10/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2004 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf | |
| 07/15/2004 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf | |
| 03/18/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf | |
| 03/18/2003 | SUPPL-18 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf | |
| 03/18/2003 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf | |
| 09/28/1999 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/03/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1992 | SUPPL-8 | 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050555s038lbl.pdf | |
| 04/24/2020 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050555s037lbl.pdf | |
| 07/15/2004 | SUPPL-22 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf | |
| 07/15/2004 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf | |
| 03/18/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf | |
| 03/18/2003 | SUPPL-18 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf |
| 03/18/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf |