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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074514

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DICLOFENAC SODIUM (DICLOFENAC SODIUM)
50MG
Marketing Status: Prescription
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: DICLOFENAC SODIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074514
Product Number: 001
Approval Date: Mar 26, 1996
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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: No
TE Code: AB
Application Number: A074514
Product Number: 002
Approval Date: Mar 26, 1996
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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