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 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
posaconazolePOSACONAZOLEMylan Institutional LLC1ebbd88b-547b-4b49-ab73-98094a2d5a792026-07-15Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
posaconazolePOSACONAZOLEGland Pharma Limited52d9d29e-4a37-4926-aa57-8477f5447b342026-06-09Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLEMajor Pharmaceuticals8e1e69b8-cf41-47cc-a3ec-1baee55f099a2026-06-01Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
posaconazolePOSACONAZOLEHikma Pharmaceuticals USA Inc.282ddea7-47d8-44e4-8806-169d7cafa9512026-05-18Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLELupin Pharmaceuticals, Inc.548124ce-8050-46a9-967b-ff23dfb186332026-05-07Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLEATLANTIC BIOLOGICALS CORP.dfbc636f-d8a7-4232-a6b0-cda49caadc9b2026-04-20Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEAmneal Pharmaceuticals NY LLC5f795eca-7a03-4c91-9a0e-c1235791b6652026-03-20Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLEENDO USA, Inc.e031b632-8e57-4359-87bd-a5da02bdc55f2026-02-18Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
NOXAFILPOSACONAZOLEMerck Sharp & Dohme LLCb073b082-7b57-4423-8c06-4fd4263d6f842026-02-13Warnings, Adverse reactionsName fallback
brand name: NOXAFIL
generic name: POSACONAZOLE
posaconazolePOSACONAZOLEGLENMARK PHARMACEUTICALS INC., USAa2ba0343-cd17-4b23-8356-005a1dfd0b352026-02-11Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
posaconazolePOSACONAZOLEGLENMARK PHARMACEUTICALS INC., USA91f89a3b-2479-4d05-9997-7b0cfaa496ec2026-02-11Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEDr.Reddys Laboratories Incd8d8dd03-46b5-bd26-bb27-7ca31d8c33262026-01-25Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEPar Health USA, LLC4032672e-1bb0-427d-a3b3-09cda4beaf342026-01-20Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEAvKAREf9c81d88-8e2c-fa53-e053-6394a90ac5c42026-01-19Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEAmerican Health Packaginge809a31a-09da-46bf-bcaa-f34b7f3b54a32025-11-17Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEBryant Ranch Prepackf15fc7d4-04ea-4be5-bfed-9a8bae74591c2025-11-11Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
PosaconazolePOSACONAZOLEBryant Ranch Prepack42a53b61-be3b-4c69-a3df-d12401dbd0e42025-06-26Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
POSACONAZOLEPOSACONAZOLEEugia US LLC2e88e379-b712-4dec-97a2-c90ef36383722025-06-07Warnings, Adverse reactionsName fallback
generic name: POSACONAZOLE
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

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