Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040731
Company: SUN PHARM INDS
Company: SUN PHARM INDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE;ORAL | Discontinued | None | No | No |
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 300MG EXTENDED | 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 |
|---|---|---|---|---|---|---|---|
| 06/30/2008 | 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 |
|---|---|---|---|---|---|
| 03/28/2023 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2023 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 01/21/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |