Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040765
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 11/12/2008 | 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 |
|---|---|---|---|---|---|
| 08/03/2023 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2023 | SUPPL-28 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2023 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 08/03/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2013 | SUPPL-4 | Labeling |
Label is not available on this site. |
EXTENDED PHENYTOIN SODIUM
CAPSULE;ORAL; 100MG EXTENDED
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILANTIN | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | Yes | AB | 084349 | VIATRIS |
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040765 | AMNEAL PHARMS NY |
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040684 | TARO |
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 204309 | AUROBINDO PHARMA |