FDA.reportPublic FDA data

Application 216167

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATECAPSULE, EXTENDED RELEASE;ORAL200MGNoNo

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
A216167-001TOPIRAMATETOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09

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 22:38:342026-08A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-0984e616aacf4f…
2026-08-18 06:07:402026-07A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-02-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-02-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORALAB12023-02-09053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216167-001TOPIRAMATE200MGCAPSULE, EXTENDED RELEASE / ORAL2023-02-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216167-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216167-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A216167-001AB11053a50430f4f…

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 3 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOPIRAMATETOPIRAMATENorthStar RxLLCb5f8da43-6daf-413c-9dcd-3636179737382026-05-20Warnings, Adverse reactionsName fallback
brand name: TOPIRAMATE
generic name: TOPIRAMATE
topiramateTOPIRAMATEREMEDYREPACK INC.5ce65b7f-9215-47a8-a784-f87a810bd7e42026-05-19Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEREMEDYREPACK INC.2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db2026-05-19Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEUpsher-Smith Laboratories, LLC691d276c-9cc1-4d39-828f-0f44d7ef63282026-05-15Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEVitruvias Therapeutics, Inc.a9d7c5ef-daf9-4f97-8673-7f4a2007f4082026-05-07Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATEGlenmark Pharmaceuticals Inc., USA54bfabce-1f8a-40ee-8b55-efce8fe6fbf12026-04-30Warnings, Adverse reactionsName fallback
brand name: TOPIRAMATE
generic name: TOPIRAMATE
topiramateTOPIRAMATEREMEDYREPACK INC.149d20de-f262-4567-aa97-d4d28a1653cb2026-04-30Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATECoupler LLC50b10a3d-883c-8891-e063-6394a90a86a12026-04-30Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA872927eb-0b61-44bb-9892-3c700b6f21812026-04-29Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEQuallent Pharmaceuticals Health LLC9dae6824-6913-42de-b98a-cdcb0d3b4a462026-04-25Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.e4886adf-199d-4b19-a4ef-75f8f94cb54e2026-04-22Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEAjanta Pharma USA Inc.b94629e3-ae2e-473e-b2f5-06e32ee19aa92026-04-20Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.a5ca2fce-bd2d-40db-b963-e3ec27c8bf232026-04-16Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.67dcdd6e-48bc-418e-a887-805929d83ce02026-04-15Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA35312f49-decf-428d-bf5f-4215b762ed3c2026-04-10Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEUnichem Pharmaceuticals (USA), Inc.6ee00e82-799d-445e-b658-a9712c49a28e2026-04-06Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEAdvagen Pharma Ltd48169bbc-4fb2-4bc4-9bdd-de71bf7722df2026-04-03Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATETeva Pharmaceuticals, Inc.4f20155f-05b9-40ec-af34-3b58aa8d60d42026-04-01Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.f72774dd-c7eb-41f9-9837-02baf77cc5232026-03-30Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATELupin Pharmaceuticals, Inc.e310afcd-1260-434e-a994-34549c789d992026-03-30Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73990ORIG 2023-04-14