Application 211593
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 82.5MG | No | No |
| 002 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 165MG | No | No |
| 003 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 330MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47781-379 | Pregabalin Extended Release | PREGABALIN | Alvogen Inc. | ANDA | Current |
| 47781-379 | Pregabalin Extended Release | PREGABALIN | Alvogen Inc. | ANDA | Current |
| 47781-380 | Pregabalin Extended Release | PREGABALIN | Alvogen Inc. | ANDA | Current |
| 47781-380 | Pregabalin Extended Release | PREGABALIN | Alvogen Inc. | ANDA | Current |
| 47781-381 | Pregabalin Extended Release | PREGABALIN | Alvogen Inc. | ANDA | Current |
| 47781-381 | Pregabalin Extended Release | PREGABALIN | Alvogen Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67402 | ORIG | 2021-05-05 |