FDA.reportPublic FDA data

Application 219507

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZONISAMIDEZONISAMIDECAPSULE;ORAL25MGNoNo
002ZONISAMIDEZONISAMIDECAPSULE;ORAL50MGNoNo
003ZONISAMIDEZONISAMIDECAPSULE;ORAL100MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219507-001ZONISAMIDEZONISAMIDE25MGCAPSULE / ORAL2025-05-12
A219507-002ZONISAMIDEZONISAMIDE50MGCAPSULE / ORAL2025-05-12
A219507-003ZONISAMIDEZONISAMIDE100MGCAPSULE / ORAL2025-05-12

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
2026-09-14 22:38:342026-08A219507-001ZONISAMIDE25MGCAPSULE / ORAL2025-05-1284e616aacf4f…
2026-09-14 22:38:342026-08A219507-002ZONISAMIDE50MGCAPSULE / ORAL2025-05-1284e616aacf4f…
2026-09-14 22:38:342026-08A219507-003ZONISAMIDE100MGCAPSULE / ORAL2025-05-1284e616aacf4f…
2026-08-18 06:07:402026-07A219507-001ZONISAMIDE25MGCAPSULE / ORAL2025-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07A219507-002ZONISAMIDE50MGCAPSULE / ORAL2025-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07A219507-003ZONISAMIDE100MGCAPSULE / ORAL2025-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219507-001ZONISAMIDE25MGCAPSULE / ORAL2025-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219507-002ZONISAMIDE50MGCAPSULE / ORAL2025-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219507-003ZONISAMIDE100MGCAPSULE / ORAL2025-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219507-001ZONISAMIDE25MGCAPSULE / ORAL2025-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219507-002ZONISAMIDE50MGCAPSULE / ORAL2025-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219507-003ZONISAMIDE100MGCAPSULE / ORAL2025-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A219507-001ZONISAMIDE25MGCAPSULE / ORAL2025-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219507-002ZONISAMIDE50MGCAPSULE / ORAL2025-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219507-003ZONISAMIDE100MGCAPSULE / ORAL2025-05-126a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219507-001ZONISAMIDE25MGCAPSULE / ORAL2025-05-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219507-002ZONISAMIDE50MGCAPSULE / ORAL2025-05-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219507-003ZONISAMIDE100MGCAPSULE / ORAL2025-05-12a50c72e98297…

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 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZonisamideZONISAMIDEAdvanced Rx of Tennessee, LLC0bc550a7-09a7-75e4-e063-6294a90a9fc12024-12-31Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
zonisamideZONISAMIDENCS HealthCare of KY, LLC dba Vangard Labs226d917a-33de-48cc-baf6-bd6a206683412024-10-23Warnings, Adverse reactionsName fallback
brand name: zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEZydus Lifesciences Limited4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f2024-08-16Name fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEAmerican Health Packaging7cdd96c4-3263-4c28-86c0-3c24bcef16c12024-05-30Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEAdvanced Rx Pharmacy of Tennessee, LLC19b059f0-a08a-f75a-e063-6294a90a57db2024-05-30Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEViona Pharmaceuticals Inc5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e2023-11-10Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
zonisamideZONISAMIDEBryant Ranch Prepack64bd9d6f-8cc0-4151-a78d-9f1437b368752023-10-24Warnings, Adverse reactionsName fallback
brand name: zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBryant Ranch Prepack2d569c8a-844b-44a8-81df-3f9c9300a79c2023-04-06Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEProficient Rx LPb4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e12022-12-01Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEUnichem Pharmaceuticals (USA), Inc.3c53d5e4-f47f-46fd-aa1c-158fd49ba9c02022-11-30Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEProficient Rx LP85321a9a-08d9-49e4-8c79-86ecfc5366132022-10-01Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEProficient Rx LP812582ce-fc7e-44b1-a428-7faa3701c1b82022-04-01Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEExelan Pharmaceuticals, Inc.24284954-0c29-458f-a9f8-97a7ad418ca72021-07-06Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE

Reported adverse events (FAERS/openFDA)#

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