Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200691
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;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 |
---|---|---|---|---|---|---|---|
12/26/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
01/06/2017 | SUPPL-2 | Labeling-Medication Guide |
Label is not available on this site. |
PHENYTOIN
TABLET, CHEWABLE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DILANTIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 084427 | PHARMACIA |
PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 040884 | EPIC PHARMA LLC |
PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 200691 | RISING |
PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 200565 | TARO |