Application 216167

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPIRAMATE	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216167-001	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL			2023-02-09

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-02-09	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216167-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2023-02-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216167-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216167-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216167-001	AB1	1	`053a50430f4f…`

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 8 · 158 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	47ef2964-3a41-4bfd-86fb-d44560b9961f	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	8abe45eb-cc75-4625-ae3d-5b2a038c4907	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	484c132f-3d3d-4218-b22f-82e9b56cc2f4	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Golden State Medical Supply, Inc.	163e9f2d-27be-6d3f-e063-6394a90a5884	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bffcd213-4f09-4a5b-8ccb-591a68be402b	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	57462baf-2f32-4bde-9627-2214c8af9370	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	12cd9be8-c5c2-4a16-9164-87963e22a88e	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Upsher-Smith Laboratories, LLC	e0d88f34-865c-441b-80e2-e814c9a7d670	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Coupler LLC	5461f33d-eaef-dce3-e063-6294a90aeff8	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Kesin Pharma	4e914420-a65b-98ba-e063-6394a90a14c4	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE
topiramate	TOPIRAMATE	AvPAK	53c3f980-f05b-c671-e063-6294a90a77d5	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	1b847969-2124-4350-94b0-ef5ba707673b	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	021005ab-6a00-40d8-9aee-20c91613b4d5	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Sun Pharmaceutical Industries, Inc.	3c909a53-ae66-4b28-a741-b60bb25a69cf	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Par Health USA, LLC	9ac09563-5967-498c-93ae-675a7f4efc48	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Par Health USA, LLC	11e0924b-fbee-4ec4-b1e4-22d7683b21ee	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Coupler LLC	52ba9c4f-e7d0-4352-e063-6394a90af7e2	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	REMEDYREPACK INC.	6f461f84-bfad-44fa-a2bd-5ea1566444b5	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	REMEDYREPACK INC.	b7539f52-06e9-4663-b401-92f5f83653cc	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE

Documents#

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