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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217511

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE)
140MG;125MG;125MG
Marketing Status: Prescription
Active Ingredient: BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Proprietary Name: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 140MG;125MG;125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217511
Product Number: 001
Approval Date: Jul 3, 2023
Applicant Holder Full Name: RICONPHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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