Sotradecol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Tetradecyl Hydrogen Sulfate (ester).
Product ID | 67457-162_5450f902-fb17-44b8-8c4b-4fefeed1908e |
NDC | 67457-162 |
Product Type | Human Prescription Drug |
Proprietary Name | Sotradecol |
Generic Name | Tetradecyl Hydrogen Sulfate (ester) |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2013-04-29 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA040541 |
Labeler Name | Mylan Institutional LLC |
Substance Name | TETRADECYL HYDROGEN SULFATE (ESTER) |
Active Ingredient Strength | 10 mg/mL |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2013-04-29 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA040541 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2012-12-19 |
Marketing Category | ANDA |
Application Number | ANDA040541 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-04-29 |
Ingredient | Strength |
---|---|
TETRADECYL HYDROGEN SULFATE (ESTER) | 10 mg/mL |
SPL SET ID: | f1756c28-dcd2-4b49-be62-07ca20682018 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
50090-4525 | Sotradecol | tetradecyl hydrogen sulfate (ester) |
50090-4529 | Sotradecol | tetradecyl hydrogen sulfate (ester) |
67457-162 | Sotradecol | tetradecyl hydrogen sulfate (ester) |
67457-163 | Sotradecol | tetradecyl hydrogen sulfate (ester) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOTRADECOL 76385054 3123924 Live/Registered |
MYLAN PHARMA GROUP LIMITED 2002-03-20 |
SOTRADECOL 71497429 0428131 Dead/Cancelled |
WALLACE & TIERNAN PRODUCTS INCORPORATED 1946-02-28 |