Application 090168
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | TABLET;ORAL | 0.5MG | No | No |
| 002 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | TABLET;ORAL | 1MG | No | No |
| 003 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8088 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8088 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8089 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8089 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10135-606 | Benztropine Mesylate | Benztropine Mesylate | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-606 | Benztropine Mesylate | Benztropine Mesylate | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-607 | Benztropine Mesylate | Benztropine Mesylate | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-607 | Benztropine Mesylate | Benztropine Mesylate | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-608 | Benztropine Mesylate | Benztropine Mesylate | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-608 | Benztropine Mesylate | Benztropine Mesylate | Marlex Pharmaceuticals Inc | ANDA | Current |
| 50090-3882 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | A-S Medication Solutions | ANDA | Current |
| 50090-3882 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | A-S Medication Solutions | ANDA | Current |
| 50090-3883 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | A-S Medication Solutions | ANDA | Current |
| 50090-3883 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | A-S Medication Solutions | ANDA | Current |
| 50090-6022 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | A-S Medication Solutions | ANDA | Current |
| 53808-1014 | Benztropine Mesylate | benztropine mesylate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1015 | Benztropine Mesylate | benztropine mesylate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1020 | Benztropine Mesylate | benztropine mesylate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 58118-0043 | Benztropine Mesylate | benztropine mesylate | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0043 | Benztropine Mesylate | benztropine mesylate | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0043 | Benztropine Mesylate | benztropine mesylate | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 63187-840 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Proficient Rx LP | ANDA | Current |
| 63187-840 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Proficient Rx LP | ANDA | Current |
| 64125-136 | Benztropine Mesylate | benztropine mesylate | Excellium Pharmaceutical, Inc, | ANDA | Current |
| 64125-137 | Benztropine Mesylate | benztropine mesylate | Excellium Pharmaceutical, Inc, | ANDA | Current |
| 64125-138 | Benztropine Mesylate | benztropine mesylate | Excellium Pharmaceutical, Inc, | ANDA | Current |
| 67046-207 | Benztropine | Benztropine | Contract Pharmacy Services-PA | ANDA | Current |
| 69315-136 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-136 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-136 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-137 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-137 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-137 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-138 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-138 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 69315-138 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Leading Pharma, LLC | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0577 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0578 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0578 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0649 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0649 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0649 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0720 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0720 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0720 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0720 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0720 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1470 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1470 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1470 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1490 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1490 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1490 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1688 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1688 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1688 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1688 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2677 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2677 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2677 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2677 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2677 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2732 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2732 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2732 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2732 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2732 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2732 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | REMEDYREPACK INC. | ANDA | Current |
| 71335-0382 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0665 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0665 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0665 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Bryant Ranch Prepack | ANDA | Current |
| 71610-502 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |