| NDC Code | 50383-261-91 |
|---|
| Package Description | 12 POUCH in 1 CARTON (50383-261-91) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE |
|---|
| Product NDC | 50383-261 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dorzolamide Hydrochloride And Timolol Maleate |
|---|
| Non-Proprietary Name | Dorzolamide Hydrochloride And Timolol Maleate |
|---|
| Dosage Form | SOLUTION/ DROPS |
|---|
| Usage | OPHTHALMIC |
|---|
| Start Marketing Date | 20190201 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA202667 |
|---|
| Manufacturer | Hi-Tech Pharmacal Co., Inc. |
|---|
| Substance Name | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
|---|
| Strength | 20; 5 |
|---|
| Strength Unit | mg/mL; mg/mL |
|---|
| Pharmacy Classes | Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC] |
|---|