FDA.reportPublic FDA data

Application 077876

Type
ANDA
Sponsor
EPIC PHARMA LLC

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 1.

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
A077876-001ZONISAMIDEZONISAMIDE25MGCAPSULE / ORAL2007-02-21
A077876-002ZONISAMIDEZONISAMIDE50MGCAPSULE / ORAL2007-02-21
A077876-003ZONISAMIDEZONISAMIDE100MGCAPSULE / ORAL2007-02-21

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 22:54:322026-06A077876-001ZONISAMIDE25MGCAPSULE / ORAL2007-02-21a50c72e98297…
2026-08-01 22:54:322026-06A077876-002ZONISAMIDE50MGCAPSULE / ORAL2007-02-21a50c72e98297…
2026-08-01 22:54:322026-06A077876-003ZONISAMIDE100MGCAPSULE / ORAL2007-02-21a50c72e98297…

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 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
zonisamideZONISAMIDECipla USA Inc.e8f368cb-6a07-4178-95fa-1d5a209171ed2026-07-27Warnings, Adverse reactionsName fallback
brand name: zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBryant Ranch Prepack467a73f0-1cd1-46bf-83b3-ee38badb761c2026-07-14Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBryant Ranch Prepack6690c2cf-1634-93c0-7b2e-0ad4ca70cd6d2026-07-13Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDESun Pharmaceutical Industries, Inc.3164d438-90bf-420a-9a56-5498b987f91c2026-06-04Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEREMEDYREPACK INC.50bb1a0a-a66d-4a13-a456-a10c1b8c8e942026-05-27Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEREMEDYREPACK INC.597f0a0b-e162-497c-9871-f2b73ebad2452026-04-06Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBluePoint Laboratories345efcc4-6a36-4ddf-8b6c-9c6c844dab0a2026-03-04Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEAurobindo Pharma Limitedab0631ca-5339-4570-bc27-f1dd92de1d6f2026-02-09Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBryant Ranch Prepack1a859304-804a-4588-9961-c2e6ae09aadb2025-11-26Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEGlenmark Pharmaceuticals Inc., USAfe15e56e-8b86-4a65-825c-31d37dd816122025-10-27Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEAvPAKb20a51ef-255e-1eb0-c0e1-461cde46b8872025-10-21Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBryant Ranch Prepack33b84aaa-044d-4c15-bb21-d1ce8674eec92025-10-13Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEBryant Ranch Prepack5000f95c-c78d-4150-9a69-0ee2943cf2c32025-10-13Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEPreferred Pharmaceuticals, Inc.53ecba6c-0de4-4e11-81d5-6deac79accd52025-10-08Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonegranZONISAMIDEAdvanz Pharma (US) Corp.d12de43e-3ac3-4335-bc85-70d7366a91eb2025-09-12Warnings, Adverse reactionsName fallback
generic name: ZONISAMIDE
ZONISADEZONISAMIDEAzurity Pharmaceuticals, Inc.ac16fa15-32e9-4f92-8bc6-d8d41ae002c62025-09-08Warnings, Adverse reactionsName fallback
generic name: ZONISAMIDE
ZonisamideZONISAMIDEREMEDYREPACK INC.40094d96-e979-4b3e-840f-a96677480f962025-08-05Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEPreferred Pharmaceuticals Inc061fdccc-d08e-4e42-8a32-54afb6c897012025-08-01Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEREMEDYREPACK INC.994e3ce0-f30b-47b1-aa42-b1ed37fb7c122025-05-30Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE
ZonisamideZONISAMIDEDirect_Rx35bcaee1-001f-82da-e063-6394a90a4a0f2025-05-22Warnings, Adverse reactionsName fallback
brand name: Zonisamide
generic name: ZONISAMIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24170ORIG2008-02-01