Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBRAMYCIN | 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 |
|---|---|---|---|---|---|---|---|
| 11/29/1993 | 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 |
|---|---|---|---|---|---|
| 06/21/2021 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/21/2021 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2020 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2001 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/05/2000 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/03/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/19/1998 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/13/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1996 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/13/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TOBRAMYCIN
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 |