FDA.reportPublic FDA data

Application 022027

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOXAFILPOSACONAZOLESUSPENSION; ORAL40MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 32 matching rows.

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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29102SUPPL2012-06-25
38106SUPPL2012-06-22
16794SUPPL2012-06-22
6717SUPPL2010-09-13
38105SUPPL2010-09-10
42392ORIG2008-09-05
38104ORIG2006-10-23
6716ORIG2006-10-23