Drugs@FDA: FDA-Approved Drugs
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/26/1973 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/01/2016 | SUPPL-53 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017381Orig1s015ltr.pdf | |
| 04/30/2015 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017381Orig1s050ltr.pdf | |
| 11/13/2012 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2004 | SUPPL-41 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17381slr041ltr.pdf |
| 09/27/2001 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1992 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1991 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1991 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1992 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/14/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/29/1987 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/1986 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/15/1985 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-27 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/06/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1982 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/10/1982 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-21 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/06/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/28/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1977 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/1977 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/11/1974 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2016 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf | |
| 08/01/2016 | SUPPL-53 | Labeling-Container/Carton Labels | 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 |
SILVADENE
CREAM;TOPICAL; 1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SILVADENE | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | Yes | AB | 017381 | KING PHARMS LLC |
| SSD | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | Yes | AB | 018578 | DR REDDYS LA |
| THERMAZENE | SILVER SULFADIAZINE | 1% | CREAM;TOPICAL | Prescription | No | AB | 018810 | THEPHARMANETWORK LLC |