Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213004

TALICIA (AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN)
250MG;EQ 10MG BASE;12.5MG
Marketing Status: Prescription
Active Ingredient: AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
Proprietary Name: TALICIA
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 250MG;EQ 10MG BASE;12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213004
Product Number: 001
Approval Date: Nov 1, 2019
Applicant Holder Full Name: REDHILL BIOPHARMA LTD
Marketing Status:  Prescription
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