Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050592s044s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050592Orig1s044,s046ltr.pdf | |
| 05/14/2021 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050592s044s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050592Orig1s044,s046ltr.pdf | |
| 04/24/2020 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050592s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050592Orig1s043ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050592s044s046lbl.pdf | |
| 05/14/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050592s044s046lbl.pdf | |
| 04/24/2020 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050592s043lbl.pdf | |
| 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 |
| TOBRAMYCIN AND DEXAMETHASONE | DEXAMETHASONE; TOBRAMYCIN | 0.1%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 212991 | AMNEAL |
| TOBRAMYCIN AND DEXAMETHASONE | DEXAMETHASONE; TOBRAMYCIN | 0.1%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 064134 | BAUSCH AND LOMB |
| TOBRAMYCIN AND DEXAMETHASONE | DEXAMETHASONE; TOBRAMYCIN | 0.1%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 212715 | PADAGIS US |