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 5 of 8 · 154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EprontiaTOPIRAMATEAzurity Pharmaceuticals, Inc.e2a4df59-fead-4a01-9021-9eda02c480102025-11-13Warnings, Adverse reactionsName fallback
generic name: TOPIRAMATE
topiramateTOPIRAMATEA-S Medication Solutionsa5cffe7a-fdee-487a-bafb-a2d43e76c23c2025-11-10Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEA-S Medication Solutionsc6918801-f22c-4ba4-a396-da484d4334ca2025-11-07Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATENCS HealthCare of KY, LLC dba Vangard Labs444464fb-6a95-4e10-99a7-fdbc7dbb4c482025-10-31Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATECardinal Health 107, LLCe5bc696e-040d-4d3e-b38c-9548a38fa9362025-10-13Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.be42ed09-350c-4e8a-aff4-6afb242dd5992025-10-01Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEPreferred Pharmaceuticals, Inc.2b6b0642-fb91-4641-9c51-d3be2021992b2025-10-01Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEAmerican Health Packaging1af94c80-2b17-409a-98f6-ce00f942351d2025-09-30Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.83558f89-1adb-4d81-b19b-68721d48034b2025-09-30Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEPreferred Pharmaceuticals, Inc.d8454fdf-7b34-49c0-b130-732e39b774b22025-09-30Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEMajor Pharmaceuticals6fb00bd8-c49e-46ef-9d6b-1b602e1d11d82025-08-25Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEA-S Medication Solutions674c2c2e-014a-43a1-91a7-7214ffc4b1d72025-08-13Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATENuCare Pharmaceuticals, Inc.490f109f-30cb-0790-e054-00144ff88e882025-07-24Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.9e516204-8f39-43c9-9f7e-d9777586f3212025-07-15Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e39d2549-b489-426d-b576-741537e112e72025-07-15Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATEXLCare Pharmaceuticals, Inc.546103e1-ea6e-466b-b0de-b1ff8c4945122025-07-02Warnings, Adverse reactionsName fallback
brand name: TOPIRAMATE
generic name: TOPIRAMATE
TopiramateTOPIRAMATEA-S Medication Solutionsf16b14a2-297f-4adb-8d7a-5f43785faef72025-06-09Warnings, Adverse reactionsName fallback
brand name: Topiramate
generic name: TOPIRAMATE
TOPIRAMATETOPIRAMATECamber Pharmaceuticals, Inc.cefbc5f4-ef5f-4732-ab96-a69a183f0b6b2025-05-22Warnings, Adverse reactionsName fallback
brand name: TOPIRAMATE
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepack49701840-5a32-4ac1-8b07-5c61decacb952025-05-01Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE
topiramateTOPIRAMATEBryant Ranch Prepackbf732c34-9078-496a-8093-f68594e76fcb2025-05-01Warnings, Adverse reactionsName fallback
brand name: topiramate
generic name: TOPIRAMATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

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