Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076886
Company: DR REDDYS
Company: DR REDDYS
| 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/2007/076886s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076886s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/17/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/2020 | SUPPL-9 | 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/2007/076886s000lbl.pdf |