Drugs@FDA: FDA-Approved Drugs
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/16/1975 | 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 |
|---|---|---|---|---|---|
| 02/16/2021 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2020 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2014 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2014 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/1998 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/19/1998 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/09/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1997 | SUPPL-33 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/27/1995 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1990 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/18/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
PHENYTOIN SODIUM
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040573 | ACELLA |
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 084307 | WEST-WARD PHARMS INT |