Product Details for NDA 005970
SOTRADECOL (SODIUM TETRADECYL SULFATE)
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SODIUM TETRADECYL SULFATE
Proprietary Name: SOTRADECOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N005970
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ELKINS SINN DIV AH ROBINS CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SOTRADECOL (SODIUM TETRADECYL SULFATE)
Proprietary Name: SOTRADECOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N005970
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ELKINS SINN DIV AH ROBINS CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SODIUM TETRADECYL SULFATE
Proprietary Name: SOTRADECOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N005970
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ELKINS SINN DIV AH ROBINS CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SOTRADECOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N005970
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ELKINS SINN DIV AH ROBINS CO INC
Marketing Status: Discontinued
Patent and Exclusivity Information