Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050541
Company: NOVARTIS
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 |
|---|---|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 211847 | ALEMBIC |
| 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 | CHARTWELL RX |
| TOBRAMYCIN | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 212628 | GLAND PHARMA LTD |
| 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 |