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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077863

DICLOFENAC SODIUM (DICLOFENAC SODIUM)
75MG
Marketing Status: Prescription
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: DICLOFENAC SODIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A077863
Product Number: 003
Approval Date: Jun 8, 2007
Applicant Holder Full Name: UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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