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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216780

LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
2%
Marketing Status: Prescription
Active Ingredient: LIDOCAINE HYDROCHLORIDE
Proprietary Name: LIDOCAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 2%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AT
Application Number: A216780
Product Number: 001
Approval Date: Mar 28, 2023
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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