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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210910

AEMCOLO (RIFAMYCIN SODIUM)
EQ 194MG BASE
Marketing Status: Discontinued
Active Ingredient: RIFAMYCIN SODIUM
Proprietary Name: AEMCOLO
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 194MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210910
Product Number: 001
Approval Date: Nov 16, 2018
Applicant Holder Full Name: REDHILL BIOPHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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