Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005970
Company: ELKINS SINN

Products on NDA 005970

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SOTRADECOL	SODIUM TETRADECYL SULFATE	1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SOTRADECOL	SODIUM TETRADECYL SULFATE	3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005970

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.html
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.html
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.html
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.html
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.html
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.html
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.html