Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091157
Company: SUN PHARM
Company: SUN PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 11/29/2019 | 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 |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 03/24/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 03/24/2023 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |