Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091025
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREGABALIN | PREGABALIN | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 75MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 225MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PREGABALIN | PREGABALIN | 300MG | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/09/2020 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2025 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2025 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/09/2023 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |