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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075229

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DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM)
25MG
Marketing Status: Prescription
Active Ingredient: DICLOFENAC POTASSIUM
Proprietary Name: DICLOFENAC POTASSIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075229
Product Number: 002
Approval Date: Sep 16, 2021
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM)
50MG
Marketing Status: Prescription
Active Ingredient: DICLOFENAC POTASSIUM
Proprietary Name: DICLOFENAC POTASSIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075229
Product Number: 001
Approval Date: Nov 20, 1998
Applicant Holder Full Name: RUBICON RESEARCH PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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