Application 203459
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
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 |
|---|
| 46708-119 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-120 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-121 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-122 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-123 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-124 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-125 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-126 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50090-4465 | Pregabalin | Pregabalin | A-S Medication Solutions | ANDA | Current |
| 62332-119 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-119 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-119 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-120 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-120 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-120 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-121 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-121 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-121 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-122 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-122 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-122 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-123 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-123 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-123 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-124 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-124 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-124 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-125 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-125 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-125 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-126 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-126 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-126 | Pregabalin | Pregabalin | Alembic Pharmaceuticals Inc. | ANDA | Current |