FDA.reportPublic FDA data

Application 083082

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATETABLET;ORAL250MGNoNo
002CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATETABLET;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A083082-001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A083082-002CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083082-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083082-002CHLOROQUINE PHOSPHATE500MGTABLET / ORAL1999-09-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A083082-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A083082-002AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A083082-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A083082-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A083082-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A083082-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A083082-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A083082-002AA1ea99ee380514…

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chloroquine PhosphateCHLOROQUINE PHOSPHATERising Pharma Holdings, Inc.ee944d28-f596-4163-a502-e779c0d622bc2026-07-02Warnings, Adverse reactionsName fallback
brand name: Chloroquine Phosphate
generic name: CHLOROQUINE PHOSPHATE
Chloroquine PhosphateCHLOROQUINE PHOSPHATERising Pharma Holdings, Inc.06c69e2b-211b-4746-9f3a-f86d365205702026-07-02Warnings, Adverse reactionsName fallback
brand name: Chloroquine Phosphate
generic name: CHLOROQUINE PHOSPHATE
Chloroquine PhosphateCHLOROQUINE PHOSPHATEAvKARE0a342f72-45f9-3e12-e063-6394a90ae33e2026-01-13Warnings, Adverse reactionsName fallback
brand name: Chloroquine Phosphate
generic name: CHLOROQUINE PHOSPHATE
CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATEChartwell RX, LLCff199f31-bfda-45f8-adbd-4662f7054f1c2025-12-10Warnings, Adverse reactionsName fallback
brand name: CHLOROQUINE PHOSPHATE
generic name: CHLOROQUINE PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1195ChloroquineChloroquine PhosphateWest-ward Pharmaceutical CorpANDACurrent
0143-2125ChloroquineChloroquine PhosphateWest-ward Pharmaceutical CorpANDACurrent
55289-856ChloroquineChloroquine PhosphatePD-Rx Pharmaceuticals, Inc.ANDACurrent
68151-0487ChloroquineChloroquine PhosphateCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39571SUPPL2009-11-16