Dorzolamide Hydrochloride and Timolol Maleate is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.
| Product ID | 50383-233_135af3fa-4438-4723-a0e8-db4efb335ec6 |
| NDC | 50383-233 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dorzolamide Hydrochloride and Timolol Maleate |
| Generic Name | Dorzolamide Hydrochloride And Timolol Maleate |
| Dosage Form | Solution/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2008-10-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077847 |
| Labeler Name | Hi-Tech Pharmacal Co., Inc. |
| Substance Name | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
| Active Ingredient Strength | 20 mg/mL; mg/mL |
| Pharm Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2009-10-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077847 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-10-28 |
| Marketing Category | ANDA |
| Application Number | ANDA077847 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-10-28 |
| Ingredient | Strength |
|---|---|
| DORZOLAMIDE HYDROCHLORIDE | 20 mg/mL |
| SPL SET ID: | 2a236f05-1ee1-4180-9d80-31518d2204c7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 24208-486 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 42571-382 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE |
| 50090-1247 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 50383-233 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 50383-261 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 60429-115 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 61314-030 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 70069-051 | DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE |
| 17478-605 | COSOPT | Dorzolamide Hydrochloride and Timolol Maleate |
| 17478-604 | COSOPT PF | Dorzolamide Hydrochloride and Timolol Maleate |
| 55545-1007 | Dorzolamide and Timolol | Dorzolamide Hydrochloride and Timolol Maleate |
| 17478-514 | Dorzolamide HCl and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 50090-2867 | Dorzolamide HCl and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate |
| 42571-147 | Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution | Dorzolamide Hydrochloride and Timolol Maleate |