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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 016084

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NDA 016084 describes ZYLOPRIM, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the ZYLOPRIM profile page.

The generic ingredient in ZYLOPRIM is allopurinol. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the allopurinol profile page.

Summary for 016084

Tradename:	ZYLOPRIM
Applicant:	Casper Pharma Llc
Ingredient:	allopurinol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 016084

Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for 016084

Antimetabolites
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants

Suppliers and Packaging for NDA: 016084

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYLOPRIM	allopurinol	TABLET;ORAL	016084	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-883	16571-883-01	100 TABLET in 1 BOTTLE (16571-883-01)
ZYLOPRIM	allopurinol	TABLET;ORAL	016084	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-883	16571-883-09	90 TABLET in 1 BOTTLE (16571-883-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 4, 2022	TE:		RLD:	Yes

Expired US Patents for NDA 016084

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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