Application 206912
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 25MG | No | No |
| 002 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 50MG | No | No |
| 003 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 75MG | No | No |
| 004 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 100MG | No | No |
| 005 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 150MG | No | No |
| 006 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 200MG | No | No |
| 007 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 225MG | No | No |
| 008 | PREGABALIN | PREGABALIN | CAPSULE;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-610 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-611 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-612 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-613 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-614 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-615 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-616 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-617 | Pregabalin | Pregabalin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 71335-1788 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1788 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1789 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1789 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1789 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1790 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1790 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1790 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1791 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1791 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1792 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1792 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1822 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1822 | Pregabalin | Pregabalin | Bryant Ranch Prepack | ANDA | Current |
| 80425-0147 | Lyrica | Pregabalin 75mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0147 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0147 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0152 | Lyrica | Pregabalin 50mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0152 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0152 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0170 | Lyrica | Pregabalin 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0170 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0170 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0178 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0178 | Pregabalin | Pregabalin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |