Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080857
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENYLAN SODIUM | PHENYTOIN SODIUM | 30MG PROMPT | CAPSULE;ORAL | Discontinued | None | No | No |
| DIPHENYLAN 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 |
|---|---|---|---|---|---|---|---|
| 12/03/1976 | 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 |
|---|---|---|---|---|---|
| 09/09/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |