Sotradecol (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Vial Label

2 mL Vial
NDC 67457-162-02

Sotradecol® 1%

(SODIUM TETRADECYL SULFATE INJECTION)

10 mg/mL

FOR IV USE ONLY

DO NOT USE IF PRECIPITATED

Rx Only

Bioniche Pharma USA LLC,
Lake Forest, IL 60045

Made in Ireland.

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Vial LabelPRINCIPAL DISPLAY PANEL — 10 mg/mL Vial Label

PRINCIPAL DISPLAY PANEL — 30 mg/mL Vial Label

2 mL Vial
NDC 67457-163-02

Sotradecol® 3%

(SODIUM TETRADECYL SULFATE INJECTION)

30 mg/mL

FOR IV USE ONLY

DO NOT USE IF PRECIPITATED

Rx Only

Bioniche Pharma USA LLC,
Lake Forest IL 60045

Made in Ireland.

PRINCIPAL DISPLAY PANEL -- 30 mg/mL Vial LabelPRINCIPAL DISPLAY PANEL — 30 mg/mL Vial Label
SOTRADECOL
tetradecyl hydrogen sulfate (ester) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-162
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tetradecyl hydrogen Sulfate (Ester) (Tetradecyl hydrogen Sulfate (Ester)) Tetradecyl hydrogen Sulfate (Ester) 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol 0.02 mL in 1 mL
Sodium Phosphate, Dibasic anhydrous 4 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-162-02 5 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
1 2 mL in 1 VIAL, GLASS This package is contained within the CARTON (67457-162-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040541 05/30/2008
SOTRADECOL
tetradecyl hydrogen sulfate (ester) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-163
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tetradecyl hydrogen Sulfate (Ester) (Tetradecyl hydrogen Sulfate (Ester)) Tetradecyl hydrogen Sulfate (Ester) 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol 0.02 mL in 1 mL
Sodium Phosphate, Dibasic anhydrous 9 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-163-02 5 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
1 2 mL in 1 VIAL, GLASS This package is contained within the CARTON (67457-163-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040541 05/30/2008
Labeler — Bioniche Pharma USA LLC (790384503)
Establishment
Name Address ID/FEI Operations
Bioniche Teoranta 896321325 MANUFACTURE

Revised: 11/2009 Bioniche Pharma USA LLC

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