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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203383

DICLOFENAC SODIUM (DICLOFENAC SODIUM)
0.1%
Marketing Status: Prescription
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: DICLOFENAC SODIUM
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.1%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A203383
Product Number: 001
Approval Date: Nov 16, 2015
Applicant Holder Full Name: ALTAIRE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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