Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076201

DICLOFENAC SODIUM (DICLOFENAC SODIUM)
100MG Marketing Status: Prescription

Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: DICLOFENAC SODIUM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A076201
Product Number: 001
Approval Date: Nov 6, 2002
Applicant Holder Full Name: DEXCEL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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