Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205098

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VARITHENA (POLIDOCANOL)
77.5MG/7.75ML (10MG/ML) Marketing Status: Prescription

Active Ingredient: POLIDOCANOL
Proprietary Name: VARITHENA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 77.5MG/7.75ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205098
Product Number: 002
Approval Date: Dec 21, 2017
Applicant Holder Full Name: PROVENSIS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

VARITHENA (POLIDOCANOL)
180MG/18ML (10MG/ML) Marketing Status: Prescription

Active Ingredient: POLIDOCANOL
Proprietary Name: VARITHENA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 180MG/18ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205098
Product Number: 001
Approval Date: Nov 25, 2013
Applicant Holder Full Name: PROVENSIS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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