Application 207883
- Type
- ANDA
- Sponsor
- PRINSTON PHARMA INC
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 |
|---|
| 43547-506 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-507 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-508 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-509 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-510 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-511 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-512 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |
| 43547-513 | PREGABALIN | pregabalin | Solco Healthcare US, LLC | ANDA | Current |