Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204803

660MG/5ML (132MG/ML)
Marketing Status: Discontinued
Active Ingredient: BUPIVACAINE
Proprietary Name: POSIMIR
Dosage Form; Route of Administration: SOLUTION, EXTENDED RELEASE; INFILTRATION
Strength: 660MG/5ML (132MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204803
Product Number: 001
Approval Date: Feb 1, 2021
Applicant Holder Full Name: DURECT CORP
Marketing Status:  Discontinued
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