FDA.reportPublic FDA data

Application 016084

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYLOPRIMALLOPURINOLTABLET;ORAL100MGYesNo
002ZYLOPRIMALLOPURINOLTABLET;ORAL300MGYesYes
003ZYLOPRIMALLOPURINOLTABLET;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-883AllopurinolallopurinolRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
16571-884AllopurinolallopurinolRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
16571-885AllopurinolallopurinolRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
65483-991ZYLOPRIMallopurinolPrometheus Laboratories Inc.NDACurrent
65483-993ZYLOPRIMallopurinolPrometheus Laboratories Inc.NDACurrent
70199-015ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-016ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-031ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-031ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-032ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-032ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-033ZyloprimallopurinolCasper Pharma LLCNDACurrent
70199-033ZyloprimallopurinolCasper Pharma LLCNDACurrent
70518-0551ZYLOPRIMallopurinolREMEDYREPACK INC.NDACurrent
70518-0551ZYLOPRIMallopurinolREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83885SUPPL 2025-10-23
83884SUPPL 2025-10-23
75541SUPPL 2023-09-22
75540SUPPL 2023-09-22
75539SUPPL 2023-09-22
75538SUPPL 2023-09-22
75537SUPPL 2023-09-22
72101SUPPL2022-09-19
71799SUPPL2022-08-15
56650SUPPL2018-12-07
56622SUPPL2018-12-04
20049SUPPL2007-07-09
415SUPPL2002-07-17