FDA.reportPublic FDA data

Application 217720

Type
ANDA
Sponsor
QILU PHARM HAINAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POSACONAZOLEPOSACONAZOLETABLET, DELAYED RELEASE;ORAL100MGNoNo

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
A217720-001POSACONAZOLEPOSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217720-001AB

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
2026-09-14 22:38:342026-08A217720-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A217720-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217720-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217720-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217720-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217720-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2025-04-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217720-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217720-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217720-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217720-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217720-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217720-001AB1a50c72e98297…

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PosaconazolePOSACONAZOLEA2A Integrated Pharmaceuticals4d14ceab-196e-4dc3-8b21-5c4629ada1612025-02-28Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLEGolden State Medical Supply, Inc.e883b495-d7e7-6d58-e053-2a95a90a1cd32025-02-24Warnings, Adverse reactionsName fallback
brand name: POSACONAZOLE
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLECamber Pharmaceuticals, Inc.c551e121-d5fc-4b35-ba9f-72ce3a314fdc2025-01-31Warnings, Adverse reactionsName fallback
brand name: POSACONAZOLE
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEAvPAKde95df83-a495-1900-e053-2995a90abf242025-01-09Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLELannett Company Inc.94a9b028-a2bc-4f41-884d-2d6c536881fc2024-12-03Warnings, Adverse reactionsName fallback
brand name: POSACONAZOLE
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEi3 Pharmaceuticals, LLCd5300d14-219d-4e1e-bfac-b413c40d6e3a2024-11-29Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
posaconazolePOSACONAZOLENovadoz Pharmaceuticals LLC0bdf77ae-3639-49c1-b7c7-533f9d0730842024-09-25Warnings, Adverse reactionsName fallback
brand name: posaconazole
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEBryant Ranch Prepackd2daba09-f1c2-4764-a567-1291be4892b92024-07-16Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEFresensius Kabi USA, LLC86be8cdb-c991-4754-b8f4-1ab79ac40bda2023-12-31Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLE DELAYED-RELEASEChartwell RX, LLCf2baa339-75ff-4c03-8334-a88648f701f72022-12-20Warnings, Adverse reactionsName fallback
brand name: POSACONAZOLE
PosaconazolePOSACONAZOLECamber Pharmaceuticals, Inc.573d89eb-05d8-4035-b406-6409f36ab7072022-12-17Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLENorthStar RxLLC4de6d839-e4bd-405c-83c5-8efc6abd08292022-12-17Warnings, Adverse reactionsName fallback
brand name: Posaconazole
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLEBiocon Phama Inc.e0e8023a-3c82-e455-a57b-ccc0206ad1562022-04-27Warnings, Adverse reactionsName fallback
brand name: POSACONAZOLE
generic name: POSACONAZOLE

Reported adverse events (FAERS/openFDA)#

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