Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078476
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
03/18/2008 | 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 |
---|---|---|---|---|---|
10/21/2019 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/21/2019 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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