Application 076416
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No |
| 002 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8274 | Tizanidine | Tizanidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8274 | Tizanidine | Tizanidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8360 | Tizanidine | Tizanidine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6898 | Tizanidine | Tizanidine | Major Pharmaceuticals | ANDA | Current |
| 42291-808 | Tizanidine | Tizanidine | AvKARE, Inc. | ANDA | Current |
| 42291-808 | Tizanidine | Tizanidine | AvKARE | ANDA | Current |
| 42291-809 | Tizanidine | Tizanidine | AvKARE, Inc. | ANDA | Current |
| 42291-809 | Tizanidine | Tizanidine | AvKARE | ANDA | Current |
| 50090-2208 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 50090-2208 | Tizanidine | Tizanidine | A-S Medication Solutions | ANDA | Current |
| 53217-211 | Tizanidine | Tizanidine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 57664-502 | Tizanidine | Tizanidine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-502 | Tizanidine | Tizanidine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-503 | Tizanidine | Tizanidine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-503 | Tizanidine | Tizanidine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 58517-380 | Tizanidine | Tizanidine | New Horizon Rx Group, LLC | ANDA | Current |
| 60760-719 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-719 | Tizanidine | Tizanidine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-673 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63187-673 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63187-673 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63187-673 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 63629-2370 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2370 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2371 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2371 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7037 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7037 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8533 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8533 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 66267-749 | Tizanidine | Tizanidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-749 | Tizanidine | Tizanidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6365 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6365 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6365 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6365 | Tizanidine | Tizanidine | Preferred Pharmaceuticals | ANDA | Current |
| 68788-6444 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6444 | Tizanidine | Tizanidine | Preferred Pharmaceuticals | ANDA | Current |
| 68788-6444 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6444 | Tizanidine | Tizanidine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1439 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1439 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1439 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1439 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3181 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3181 | Tizanidine | Tizanidine | REMEDYREPACK INC. | ANDA | Current |
| 70934-268 | Tizanidine | Tizanidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-268 | Tizanidine | Tizanidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-311 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 71205-311 | Tizanidine | Tizanidine | Proficient Rx LP | ANDA | Current |
| 71335-1016 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1016 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1799 | Tizanidine | Tizanidine | Bryant Ranch Prepack | ANDA | Current |
| 71610-167 | Tizanidine | Tizanidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-345 | Tizanidine | Tizanidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-451 | Tizanidine | Tizanidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 80425-0022 | Zanaflex | Tizanidine HCL | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0022 | Tizanidine HCL | Tizanidine HCL | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0022 | Tizanidine HCL | Tizanidine HCL | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |