FDA.reportPublic FDA data

Application 202610

Type
ANDA
Sponsor
THEPHARMANETWORK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISONIAZIDISONIAZIDTABLET;ORAL100MGNoNo
002ISONIAZIDISONIAZIDTABLET;ORAL300MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202610-001ISONIAZIDISONIAZID100MGTABLET / ORALAA2014-10-29
A202610-002ISONIAZIDISONIAZID300MGTABLET / ORALAA2014-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202610-001AA
A202610-002AA

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 22:54:322026-06A202610-001ISONIAZID100MGTABLET / ORALAA2014-10-29a50c72e98297…
2026-08-01 22:54:322026-06A202610-002ISONIAZID300MGTABLET / ORALAA2014-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202610-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A202610-002AA1a50c72e98297…

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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
IsoniazidISONIAZIDREMEDYREPACK INC.6dab7b7b-a3a9-47ef-b423-134bc6970d8b2026-01-05Boxed 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