FDA.reportPublic FDA data

Application 080935

Type
ANDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INHISONIAZIDTABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A080935-001INHISONIAZID300MGTABLET / ORALApproved before 1982

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080935-001INH300MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080935-001INH300MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080935-001INH300MGTABLET / ORALApproved before 1982a50c72e98297…

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

Reported adverse events (FAERS/openFDA)#

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