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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209511

XARACOLL (BUPIVACAINE HYDROCHLORIDE)
100MG
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: XARACOLL
Dosage Form; Route of Administration: IMPLANT; IMPLANTATION
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209511
Product Number: 001
Approval Date: Aug 28, 2020
Applicant Holder Full Name: INNOCOLL PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information
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