| NDC Code | 68083-490-01 |
|---|
| Package Description | 1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE |
|---|
| Product NDC | 68083-490 |
|---|
| 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 | 20220919 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA215520 |
|---|
| Manufacturer | Gland Pharma Limited |
|---|
| 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] |
|---|