Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050616
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBRADEX | DEXAMETHASONE; TOBRAMYCIN | 0.1%;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 |
|---|---|---|---|---|---|---|---|
| 09/28/1988 | 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-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050616s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050616Orig1s040,s041ltr.pdf | |
| 05/14/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050616s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050616Orig1s040,s041ltr.pdf | |
| 04/24/2020 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050616s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050616Orig1s039ltr.pdf | |
| 07/15/2004 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf | |
| 07/15/2004 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf | |
| 03/18/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf | |
| 12/11/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s018.pdf |
| 03/18/2003 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf | |
| 03/18/2003 | SUPPL-16 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf | |
| 09/28/1999 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s015.pdf |
| 04/07/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s011.pdf |
| 11/29/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s010.pdf |
| 09/26/1996 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/50-616S009.pdf |
| 03/18/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s008.pdf |
| 10/27/1994 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s007.pdf |
| 02/03/1992 | SUPPL-6 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s006.pdf |
| 05/21/1992 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s005.pdf |
| 08/31/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s003pdf |
| 09/17/1992 | SUPPL-2 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s002.pdf |
| 06/27/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/050616Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050616s040s041lbl.pdf | |
| 05/14/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050616s040s041lbl.pdf | |
| 04/24/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050616s039lbl.pdf | |
| 07/15/2004 | SUPPL-22 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf | |
| 07/15/2004 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf | |
| 03/18/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf | |
| 03/18/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf | |
| 03/18/2003 | SUPPL-16 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf |