Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005970
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SOTRADECOL SODIUM TETRADECYL SULFATE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
SOTRADECOL SODIUM TETRADECYL SULFATE 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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

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