Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040541

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SOTRADECOL (SODIUM TETRADECYL SULFATE)
20MG/2ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM TETRADECYL SULFATE
Proprietary Name: SOTRADECOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A040541
Product Number: 001
Approval Date: Nov 12, 2004
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SOTRADECOL (SODIUM TETRADECYL SULFATE)
60MG/2ML (30MG/ML)
Marketing Status: Prescription
Active Ingredient: SODIUM TETRADECYL SULFATE
Proprietary Name: SOTRADECOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 60MG/2ML (30MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A040541
Product Number: 002
Approval Date: Nov 12, 2004
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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