Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBREX | TOBRAMYCIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/13/1984 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2021 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2021 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/13/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/03/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2002 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/21/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/04/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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 |