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Details for New Drug Application (NDA): 018297

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NDA 018297 describes LOPURIN, which is a drug marketed by Dr Reddys La and Abbott and is included in three NDAs. It is available from seven suppliers. Additional details are available on the LOPURIN profile page.

The generic ingredient in LOPURIN 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: 018297

Tradename:
LOPURIN
Applicant:
Abbott
Ingredient:
allopurinol
Patents:0
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018297

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbott
LOPURIN
allopurinol
TABLET;ORAL018297-001Approved Prior to Jan 1, 19823,624,205► subscribe
Abbott
LOPURIN
allopurinol
TABLET;ORAL018297-002Approved Prior to Jan 1, 19823,624,205► subscribe
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