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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216184

Marketing Status: Prescription
Active Ingredient: INDOMETHACIN
Proprietary Name: INDOMETHACIN
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216184
Product Number: 001
Approval Date: Aug 2, 2023
Applicant Holder Full Name: ZYDUS WORLDWIDE DMCC
Marketing Status:  Prescription
Patent and Exclusivity Information
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