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Application 211685
- Type
- ANDA
- Sponsor
- APOTEX
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 |
|---|
| 60505-3793 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3794 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3795 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3796 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3797 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3798 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3799 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |
| 60505-3800 | Pregabalin | Pregabalin | ApotexCorp | ANDA | Current |