FDA.reportPublic FDA data

Application 078439

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL2MGNoNo
002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL4MGNoNo

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 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETrigen Laboratories, LLC8bb81796-6990-40e9-bee4-1f292f91ae992025-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEPadagis US LLC780a2616-0392-4715-bc50-71799bea19572025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydromorphone hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEASCLEMED USA INC.18f6f54e-1537-4181-9d07-54ddf881a9ee2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDECamber Pharmaceuticals, Inc.c33e6320-4206-4b69-8cac-ebfc2351b8f22025-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydromorphone hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAscent Pharmaceuticals Inc4de15afe-d676-4faa-a34d-9b9cb20dbf542024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROMORPHONE HYDROCHLORIDE
generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack29765ff0-3b1d-47da-953e-28bf0e6a56ef2024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROMORPHONE HYDROCHLORIDE
generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.90bda45c-9dbe-4ed5-91d0-df8446ad70262024-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydromorphone hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackbec32a94-4b79-4bd4-b000-45e9030d31062024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROMORPHONE HYDROCHLORIDE
generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAurolife Pharma, LLCf778dfab-e109-428e-b1b7-4dfb1b8293e42023-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROMORPHONE HYDROCHLORIDE
generic name: HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEPadagis US LLC1bfbba46-1979-4797-a29e-d677181316862023-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROMORPHONE HYDROCHLORIDE
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAscent Pharmaceuticals Ince8fd7b0e-22b9-4f8a-8eb2-41d5031779af2017-05-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
52959-408Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-420Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
68084-423Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-472Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingANDACurrent