Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040731
Company: SUN PHARM INDS
Company: SUN PHARM INDS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 200MG EXTENDED | CAPSULE;ORAL | Prescription | AB | No | No |
EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 300MG EXTENDED | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/30/2008 | 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 |
---|---|---|---|---|---|
03/28/2023 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/28/2023 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/21/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
EXTENDED PHENYTOIN SODIUM
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 |