FDA.reportPublic FDA data

Application 089816

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISONIAZIDISONIAZIDInjectable; Injection100MG/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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsoniazidISONIAZIDREMEDYREPACK INC.6dab7b7b-a3a9-47ef-b423-134bc6970d8b2026-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDREMEDYREPACK INC.93252cc8-c8d4-401b-bde5-ca8a3b57651e2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDBryant Ranch Prepack03bf3bd5-64f9-4491-89fd-96c5c10d01292026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDChartwell RX, LLC8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDCoupler LLC44592c5c-d11c-148d-e063-6294a90ab35c2025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDBryant Ranch Prepackb6d6dccc-2577-4bbb-896e-5f75b65ee6ca2025-10-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDA-S Medication Solutionsed780e28-a2c3-44dc-898a-d2cbe05eeedf2025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDMarlex Pharmaceuticals, Inc.312cd403-b211-64ef-e063-6394a90aab882025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDBryant Ranch Prepack9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c2025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDOMNIVIUM PHARMACEUTICALS LLC.35400f1d-fd25-4bfa-a382-ac390e21bf2e2025-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDCoupler LLC38f4c4af-81da-9b0c-e063-6294a90a8b9d2025-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDGenus Lifesciencesf0b46d1d-2300-457d-a7bd-a88a3f8d22352025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDA-S Medication Solutionsd5039796-6ba0-4fa8-84f7-e47c63d451632025-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDSandoz Inc77795c31-1cdf-4a20-b4a1-cd15f5b310f12025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDChartwell RX, LLC2e09b1a5-9786-427f-bf00-be15b06eb7e72025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDBryant Ranch Prepackeeaf09a3-5631-4089-9f17-15750c002e322025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
isoniazidISONIAZIDBryant Ranch Prepack63bf1fe0-5d74-4123-88b7-a95d521befca2025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDMylan Institutional Inc.60a6b514-fa7f-4bc7-85b0-e5a14fa56b592025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDCMP Pharma, Inc.db8a3ae7-fb5b-47a9-a9f7-f57cd90501c22024-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID
IsoniazidISONIAZIDA-S Medication Solutions8a309582-1bb7-4b21-af43-c38710ac83d52023-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Isoniazid
generic name: ISONIAZID

Reported adverse events (FAERS/openFDA)#

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