Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006459
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HETRAZAN | DIETHYLCARBAMAZINE CITRATE | 50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/13/1950 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1991 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/07/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |