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Generated: September 20, 2018

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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 three 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-nine 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 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 REMEDYREPACK INC. 61786-801 61786-801-02 30 TABLET in 1 BLISTER PACK (61786-801-02)
ZYLOPRIM allopurinol TABLET;ORAL 016084 NDA Prometheus Laboratories Inc. 65483-991 65483-991-10 100 TABLET in 1 BOTTLE (65483-991-10)

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

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

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