Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 004054
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFADIAZINE | SULFADIAZINE | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| SULFADIAZINE SODIUM | SULFADIAZINE SODIUM | 250MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/11/1941 | 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 |
|---|---|---|---|---|---|
| 01/14/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1978 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1977 | SUPPL-1 |
Label is not available on this site. |