FDA.reportPublic FDA data

Application 216326

Type
ANDA
Sponsor
WELDING

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A216326-001POSACONAZOLEPOSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2023-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216326-001AB

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
2026-08-01 22:54:322026-06A216326-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2023-06-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216326-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 34 matching rows.

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