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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 050786


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NDA 050786 describes PYLERA, which is a drug marketed by Labs Juvise and is included in one NDA. It is available from one supplier. Additional details are available on the PYLERA profile page.

The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
Summary for 050786
Pharmacology for NDA: 050786
Suppliers and Packaging for NDA: 050786
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYLERA bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride CAPSULE;ORAL 050786 NDA H2-Pharma, LLC 61269-380 61269-380-12 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK
PYLERA bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride CAPSULE;ORAL 050786 NDA H2-Pharma, LLC 61269-385 61269-385-12 1 BLISTER PACK in 1 BOX (61269-385-12) / 120 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG;125MG;125MG
Approval Date:Sep 28, 2006TE:ABRLD:Yes

Expired US Patents for NDA 050786

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