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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208021

DICLOFENAC SODIUM (DICLOFENAC SODIUM)
2%
Marketing Status: Prescription
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: DICLOFENAC SODIUM
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 2%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A208021
Product Number: 001
Approval Date: Sep 20, 2022
Applicant Holder Full Name: LUPIN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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