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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216814

IBUPROFEN AND FAMOTIDINE (FAMOTIDINE; IBUPROFEN)
26.6MG;800MG
Marketing Status: Prescription
Active Ingredient: FAMOTIDINE; IBUPROFEN
Proprietary Name: IBUPROFEN AND FAMOTIDINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 26.6MG;800MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216814
Product Number: 001
Approval Date: Mar 15, 2023
Applicant Holder Full Name: ASCENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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