FDA.reportPublic FDA data

Application 070147

Type
ANDA
Sponsor
PURACAP PHARM

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070147-001ALLOPURINOLALLOPURINOL300MGTABLET / ORAL1985-12-10

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A070147-001ALLOPURINOL300MGTABLET / ORAL1985-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070147-001ALLOPURINOL300MGTABLET / ORAL1985-12-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070147-001ALLOPURINOL300MGTABLET / ORAL1985-12-10a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLREMEDYREPACK INC.8f50e91e-66a7-4fd4-888a-9f1986aa661c2026-09-10Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLDr. Reddy's Laboratories Limited19a138b8-d225-03e6-f762-abe71560204b2026-09-03Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLREMEDYREPACK INC.4dbced9a-ef6f-455e-8d5d-b635409521db2026-09-03Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLREMEDYREPACK INC.165f2ebb-a099-4d31-b21a-93b341c394292026-08-27Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLREMEDYREPACK INC.36526c80-5a70-47c4-a0a6-785ccc3467032026-08-14Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLREMEDYREPACK INC.5ffcbc32-5996-41cd-acdc-cc4af8cdaf4f2026-08-14Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.f1c11f74-1de2-484c-b40b-d0013e8fd01a2026-08-07Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.f130c9c0-45d8-42bc-a040-04bb077671f82026-08-07Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.b2ab2389-ccaf-487b-9985-50e3539e76172026-08-07Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.211e47c6-85b9-43e8-9e07-6cc4b8f708a02026-08-07Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
ALLOPURINOLALLOPURINOLAphena Pharma Solutions - Tennessee, LLC583df4b8-a1d4-01ed-e063-6394a90af0072026-08-04Warnings, Adverse reactionsName fallback
brand name: ALLOPURINOL
generic name: ALLOPURINOL
AllopurinolALLOPURINOLSun Pharmaceutical Industries, Inc.fd8f8b8b-f25e-46e9-969a-65363b66e09b2026-07-31Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLCardinal Health 107, LLCced59048-c147-4702-af32-2f9b517ed87a2026-07-24Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLCardinal Health 107, LLCb6c5b5c0-b1cb-44c0-a849-5d317e6fa3002026-07-21Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLREMEDYREPACK INC.55280a8a-cf23-405b-b698-95a4d8e3c6992026-07-14Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLBryant Ranch Prepack6341a72d-9c83-448c-871b-e800ad8f15472026-07-13Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
ALLOPURINOLALLOPURINOLAphena Pharma Solutions - Tennessee, LLC5644814c-3f61-5338-e063-6294a90ad6c92026-07-10Warnings, Adverse reactionsName fallback
brand name: ALLOPURINOL
generic name: ALLOPURINOL
AllopurinolALLOPURINOLMajor Pharmaceuticals8c0f5af5-a453-4641-933f-ccb2625fca392026-06-24Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLBryant Ranch Prepack156d743c-6324-44db-9230-21f762d64cfd2026-06-11Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL
AllopurinolALLOPURINOLBryant Ranch Prepackb943dbb1-7f54-434c-9439-8ce768d94ff42026-06-10Warnings, Adverse reactionsName fallback
brand name: Allopurinol
generic name: ALLOPURINOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.