.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016084

« Back to Dashboard
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-one suppliers are listed for this compound. Additional details are available on the allopurinol profile page.

Summary for NDA: 016084

Tradename:
ZYLOPRIM
Applicant:
Sebela Ireland Ltd
Ingredient:
allopurinol
Patents:0
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
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)

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
ZYLOPRIM
allopurinol
TABLET;ORAL016084-001Approved Prior to Jan 1, 19823,624,205► subscribe
Sebela Ireland Ltd
ZYLOPRIM
allopurinol
TABLET;ORAL016084-002Approved Prior to Jan 1, 19823,624,205► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc