Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021201

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ASCLERA (POLIDOCANOL)
10MG/2ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: POLIDOCANOL
Proprietary Name: ASCLERA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021201
Product Number: 001
Approval Date: Mar 30, 2010
Applicant Holder Full Name: CHEMISCHE FABRIK KREUSSLER & CO. GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
ASCLERA (POLIDOCANOL)
20MG/2ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: POLIDOCANOL
Proprietary Name: ASCLERA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20MG/2ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021201
Product Number: 002
Approval Date: Mar 30, 2010
Applicant Holder Full Name: CHEMISCHE FABRIK KREUSSLER & CO. GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

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