FDA.reportPublic FDA data

Application 077733

Type
ANDA
Sponsor
VIWIT PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077733-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A077733-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A077733-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A077733-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077733-001AB
A077733-002AB
A077733-003AB
A077733-004AB

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 22:54:322026-06A077733-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A077733-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A077733-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A077733-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077733-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077733-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077733-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A077733-004AB1a50c72e98297…

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 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEREMEDYREPACK INC.610d4df7-703f-4070-9adc-3e57ca05a2f12026-07-30Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.4833f2e8-16b7-406f-937a-55bc978bf92c2026-07-29Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEREMEDYREPACK INC.44095c2b-2e90-45d2-ab45-d0961c41550d2026-07-20Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEREMEDYREPACK INC.7e0834ee-920b-496f-954d-f9d81c3ba2d62026-07-17Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEREMEDYREPACK INC.b71c09c5-43dd-4d98-9ab6-0b0c99908cac2026-07-09Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEREMEDYREPACK INC.f8aaf403-0e15-4bbb-b88b-253d934396882026-07-09Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEUnit Dose Solutions, Inc.562f3fec-489b-4662-e063-6294a90a4ea22026-07-09Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEREMEDYREPACK INC.0366164b-1846-443d-9564-dbe52d8d9b652026-07-08Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy46a305cb-ab73-0bca-e063-6294a90a9b852026-07-08Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e846124d-e9e6-42c7-83f1-5df170d3f70b2026-07-07Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATECoupler LLC55f2aca4-b961-a746-e063-6294a90ae8ce2026-07-06Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEREMEDYREPACK INC.0cf388dc-d8f1-4478-bf5f-e64638ee58012026-06-29Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy92637f92-9d7c-c246-e053-2995a90a03472026-06-26Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy9221403c-467f-738e-e053-2995a90ac8fd2026-06-26Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepack8abe45eb-cc75-4625-ae3d-5b2a038c49072026-06-24Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEGolden State Medical Supply, Inc.163e9f2d-27be-6d3f-e063-6394a90a58842026-06-24Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepackbffcd213-4f09-4a5b-8ccb-591a68be402b2026-06-24Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepack57462baf-2f32-4bde-9627-2214c8af93702026-06-24Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23884ORIG2009-04-14