You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 078253


✉ Email this page to a colleague

« Back to Dashboard


NDA 078253 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Chartwell, Endo Operations, Harman Finochem, Hetero Labs Ltd V, Indoco, Ipca Labs Ltd, Lupin Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Gland Pharma Ltd, and Hikma, and is included in thirty NDAs. It is available from thirty-eight suppliers. Additional details are available on the ALLOPURINOL profile page.

The generic ingredient in ALLOPURINOL is allopurinol sodium. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
Summary for 078253
Tradename:ALLOPURINOL
Applicant:Northstar Hlthcare
Ingredient:allopurinol
Patents:0
Pharmacology for NDA: 078253
Mechanism of ActionXanthine Oxidase Inhibitors
Medical Subject Heading (MeSH) Categories for 078253
Suppliers and Packaging for NDA: 078253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLOPURINOL allopurinol TABLET;ORAL 078253 ANDA Northstar RxLLC 16714-041 16714-041-07 30 TABLET in 1 BOTTLE (16714-041-07)
ALLOPURINOL allopurinol TABLET;ORAL 078253 ANDA Northstar RxLLC 16714-041 16714-041-10 100 TABLET in 1 BOTTLE (16714-041-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 11, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 11, 2007TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.