FDA.reportPublic FDA data

Application 075798

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALLOPURINOLALLOPURINOLTABLET;ORAL100MGNoNo
002ALLOPURINOLALLOPURINOLTABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075798-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB2003-06-27
A075798-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB2003-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075798-001AB
A075798-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27a50c72e98297…
2026-08-01 22:54:322026-06A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075798-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075798-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLCardinal Health 107, LLCb6c5b5c0-b1cb-44c0-a849-5d317e6fa3002026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 55154-7981
AllopurinolALLOPURINOLMajor Pharmaceuticals8c0f5af5-a453-4641-933f-ccb2625fca392026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 0904-6572
AllopurinolALLOPURINOLNCS HealthCare of KY, LLC dba Vangard Labs1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c32026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 0615-8385
AllopurinolALLOPURINOLREMEDYREPACK INC.4dbced9a-ef6f-455e-8d5d-b635409521db2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack73a374a6-ea1a-40a1-b6eb-d42654df08952024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 63629-2112
AllopurinolALLOPURINOLBryant Ranch Prepackf91c2183-e41d-45bc-87aa-edfca5eebac52024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 63629-2111
AllopurinolALLOPURINOLBryant Ranch Prepack005048dd-844f-468c-bf56-1a09727e34772024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 63629-2113
AllopurinolALLOPURINOLBryant Ranch Prepack90912dd4-5abf-4fd3-8fc1-3afd057b743f2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepacke84cd8df-79d8-449f-ace2-5a4de1cdaf512024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLPar Health USA, LLCfbac3b4f-dc23-4359-ac3f-2b3fdde41af22024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 0603-2115
ndc (product): 0603-2116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-2115AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2115AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2115AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2115AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2115AllopurinolallopurinolPar Pharmaceutical, Inc.ANDACurrent
0603-2116AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2116AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2116AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2116AllopurinolallopurinolPar PharmaceuticalANDACurrent
0603-2116AllopurinolallopurinolPar Pharmaceutical, Inc.ANDACurrent
0615-8385AllopurinolallopurinolNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-6571AllopurinolallopurinolMajor PharmaceuticalsANDACurrent
0904-6571AllopurinolallopurinolMajor PharmaceuticalsANDACurrent
0904-6571AllopurinolallopurinolMajor PharamceuticalsANDACurrent
0904-6572AllopurinolallopurinolMajor PharmaceuticalsANDACurrent
0904-6572AllopurinolallopurinolMajor PharmaceuticalsANDACurrent
0904-6572AllopurinolallopurinolMajor PharmaceuticalsANDACurrent
0904-6572AllopurinolallopurinolMajor PharamceuticalsANDACurrent
0904-6572AllopurinolallopurinolMajor PharmaceuticalsANDACurrent
43063-079AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-079AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-079AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-079AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-079AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
50268-063AllopurinolallopurinolAvPAKANDACurrent
50268-063AllopurinolallopurinolAvPAKANDACurrent
50268-063AllopurinolallopurinolAvPAKANDACurrent
50268-064AllopurinolallopurinolAvPAKANDACurrent
50268-064AllopurinolallopurinolAvPAKANDACurrent
50268-064AllopurinolallopurinolAvPAKANDACurrent
55154-7892AllopurinolallopurinolCardinal HealthANDACurrent
55154-7892AllopurinolallopurinolCardinal HealthANDACurrent
55154-7981AllopurinolallopurinolCardinal Health 107, LLCANDACurrent
55154-7981AllopurinolallopurinolCardinal HealthANDACurrent
55154-7981AllopurinolallopurinolCardinal HealthANDACurrent
55289-010AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-010AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-010AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-010AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-010AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-010AllopurinolallopurinolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-035AllopurinolallopurinolLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-114AllopurinolALLOPURINOLSt Marys Medical Park PharmacyANDACurrent
63629-2111AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-2111AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-2111AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-2112AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-2112AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-2113AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-2113AllopurinolallopurinolBryant Ranch PrepackANDACurrent
67046-008AllopurinolallopurinolContract Pharmacy Services-PAANDACurrent
67296-1314AllopurinolAllopurinolRedPharm Drug, Inc.ANDACurrent
67296-1314AllopurinolAllopurinolRedPharm Drug, Inc.ANDACurrent
67296-1314AllopurinolAllopurinolRedPharm Drug, Inc.ANDACurrent
67544-371AllopurinolallopurinolAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
67544-988AllopurinolallopurinolAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
70518-0190AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0476AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent