Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078126
Company: APOTEX INC
Company: APOTEX INC
| 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 |
|---|---|---|---|---|---|---|---|
| 08/06/2007 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/03/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2016 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/06/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf |
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