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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 Sebela Ireland Ltd 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-one drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the allopurinol profile page.

Summary for NDA: 016084

Sebela Ireland Ltd
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 016084

Mechanism of ActionXanthine Oxidase Inhibitors

Suppliers and Packaging for NDA: 016084

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 016084 NDA REMEDYREPACK INC. 61786-801 61786-801-02 30 TABLET in 1 BLISTER PACK (61786-801-02)
TABLET;ORAL 016084 NDA Prometheus Laboratories Inc. 65483-991 65483-991-10 100 TABLET in 1 BOTTLE (65483-991-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 016084

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
TABLET;ORAL016084-001Approved Prior to Jan 1, 19823,624,205► subscribe
Sebela Ireland Ltd
TABLET;ORAL016084-002Approved Prior to Jan 1, 19823,624,205► subscribe
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