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

Tradename:	PYLERA
Applicant:	Labs Juvise
Ingredient:	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Patents:	0

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:	RX	Dosage:	CAPSULE;ORAL			Strength	140MG;125MG;125MG
Approval Date:	Sep 28, 2006	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050786

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	⤷ Sign Up	⤷ Sign Up
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	⤷ Sign Up	⤷ Sign Up
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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