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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018185

INDOCIN SR (INDOMETHACIN)
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: INDOMETHACIN
Proprietary Name: INDOCIN SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018185
Product Number: 001
Approval Date: Feb 23, 1982
Applicant Holder Full Name: ZYLA LIFE SCIENCES US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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