TOBRADEX ST is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Tobramycin; Dexamethasone.
| Product ID | 0065-0652_83c0535a-a158-4cbf-b3f8-d1bd6658015b |
| NDC | 0065-0652 |
| Product Type | Human Prescription Drug |
| Proprietary Name | TOBRADEX ST |
| Generic Name | Tobramycin / Dexamethasone |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2010-09-07 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050818 |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | TOBRAMYCIN; DEXAMETHASONE |
| Active Ingredient Strength | 3 mg/mL; mg/mL |
| Pharm Classes | Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2010-09-07 |
| Marketing End Date | 2021-06-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA050818 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-09 |
| Marketing Category | NDA |
| Application Number | NDA050818 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-07 |
| Marketing End Date | 2010-09-07 |
| Marketing Category | NDA |
| Application Number | NDA050818 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-07 |
| Marketing End Date | 2010-09-07 |
| Marketing Category | NDA |
| Application Number | NDA050818 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-09-07 |
| Ingredient | Strength |
|---|---|
| TOBRAMYCIN | 3 mg/mL |
| SPL SET ID: | d1d48422-8cfc-4e9e-a7f8-56c274d8eb83 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-0652 | TOBRADEX ST | tobramycin / dexamethasone |
| 71776-035 | TobraDex ST | tobramycin / dexamethasone |