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Last Updated: November 21, 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
Pharmacology for NDA: 016084
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 016084
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:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 4, 2022TE:ABRLD:Yes

Expired US Patents for NDA 016084

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

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