Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017381
Company: KING PHARMS LLC
Company: KING PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SILVADENE | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2016 | SUPPL-53 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf | |
| 08/01/2016 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf | |
| 03/06/2013 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf |