Drugs@FDA: FDA-Approved Drugs
Company: ELKINS SINN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOTRADECOL | SODIUM TETRADECYL SULFATE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
SOTRADECOL | SODIUM TETRADECYL SULFATE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/13/1946 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
03/09/2001 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/18/1991 | SUPPL-35 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S35_Sotradecol_toc.cfm |
01/16/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
01/12/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
06/23/1988 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
03/31/1987 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/31/1987 | SUPPL-30 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S30_Sotradecol_toc.cfm |
01/29/1988 | SUPPL-28 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S28_Sotradecol_toc.cfm |
08/24/1985 | SUPPL-27 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S27_Sotradecol_toc.cfm |
03/02/1983 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/23/1979 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/26/1978 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/03/1977 | SUPPL-22 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S22_Sotradecol_toc.cfm |
03/16/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
03/11/1975 | SUPPL-18 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S18_Sotradecol_toc.cfm |
02/03/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/14/1972 | SUPPL-13 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/005970-S13_Sotradecol_toc.cfm |