Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212715
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBRAMYCIN AND DEXAMETHASONE | DEXAMETHASONE; TOBRAMYCIN | 0.1%;0.3% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TOBRAMYCIN AND DEXAMETHASONE
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 | SANDOZ |
| 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 |