Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203995

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DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM; MISOPROSTOL)
50MG;0.2MG
Marketing Status: Prescription

Active Ingredient: DICLOFENAC SODIUM; MISOPROSTOL
Proprietary Name: DICLOFENAC SODIUM AND MISOPROSTOL
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 50MG;0.2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203995
Product Number: 001
Approval Date: Nov 25, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information

DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM; MISOPROSTOL)
75MG;0.2MG
Marketing Status: Prescription

Active Ingredient: DICLOFENAC SODIUM; MISOPROSTOL
Proprietary Name: DICLOFENAC SODIUM AND MISOPROSTOL
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 75MG;0.2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203995
Product Number: 002
Approval Date: Nov 25, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information