Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Discontinued | None | No | No |
| PHENYTEK | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE;ORAL | Prescription | AB | No | No |
| PHENYTEK | PHENYTOIN SODIUM | 300MG EXTENDED | CAPSULE;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/28/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40298ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040298_phenytoin-sodium_TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/01/2024 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2024 | SUPPL-44 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/01/2024 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2024 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/01/2024 | SUPPL-36 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/27/2016 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2014 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2014 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2014 | SUPPL-28 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/08/2014 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/18/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/20/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/20/2002 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/20/2002 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/19/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf |
| 12/06/2001 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf |
| 12/06/2001 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf |
| 01/17/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/2001 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/10/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/28/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf |
EXTENDED PHENYTOIN SODIUM
There are no Therapeutic Equivalents.
PHENYTEK
CAPSULE;ORAL; 200MG EXTENDED
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040731 | SUN PHARM INDS |
| PHENYTEK | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040298 | MYLAN |
CAPSULE;ORAL; 300MG EXTENDED
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 300MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040731 | SUN PHARM INDS |
| PHENYTEK | PHENYTOIN SODIUM | 300MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040298 | MYLAN |