Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085435
Company: PHARMERAL
Company: PHARMERAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG PROMPT | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/15/1977 | 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 |
---|---|---|---|---|---|
11/02/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |