Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040420
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENYTOIN | PHENYTOIN | 125MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 04/19/2002 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40420ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040420_PhenytoinTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/02/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/09/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/06/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |