Application 020844

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPAMAX	TOPIRAMATE	CAPSULE;ORAL	15MG	Yes	No
002	TOPAMAX	TOPIRAMATE	CAPSULE;ORAL	25MG	Yes	Yes
003	TOPAMAX SPRINKLE	TOPIRAMATE	CAPSULE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020844-001	TOPAMAX	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26
N020844-002	TOPAMAX	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26
N020844-003	TOPAMAX SPRINKLE	TOPIRAMATE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020844-001	AB
N020844-002	AB

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.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020844-002	TOPAMAX	25MG	CAPSULE / ORAL	AB	RLD, RS	1998-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020844-003	TOPAMAX SPRINKLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1998-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020844-001	TOPAMAX	15MG	CAPSULE / ORAL	AB	RLD	1998-10-26	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020844-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020844-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020844-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020844-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020844-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020844-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020844-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020844-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020844-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020844-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020844-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020844-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020844-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020844-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020844-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020844-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020844-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020844-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020844-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020844-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020844-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020844-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020844-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020844-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020844-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020844-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020844-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020844-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020844-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020844-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020844-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020844-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020844-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020844-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020844-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020844-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020844-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020844-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020844-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020844-002	AB	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020844-001	7125560	2019-03-01	U-766		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020844-001	7125560*PED	2019-09-01		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020844-002	7125560	2019-03-01	U-766		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020844-002	7125560*PED	2019-09-01		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020844-003	7125560	2019-03-01	U-766		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020844-003	7125560*PED	2019-09-01		Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020844-001	7125560	2019-03-01	U-766		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020844-001	7125560*PED	2019-09-01		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020844-002	7125560	2019-03-01	U-766		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020844-002	7125560*PED	2019-09-01		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020844-003	7125560	2019-03-01	U-766		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020844-003	7125560*PED	2019-09-01		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020844-001	7125560	2019-03-01	U-766		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020844-001	7125560*PED	2019-09-01		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020844-002	7125560	2019-03-01	U-766		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020844-002	7125560*PED	2019-09-01		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020844-003	7125560	2019-03-01	U-766		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020844-003	7125560*PED	2019-09-01		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020844-001	7125560	2019-03-01	U-766		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020844-001	7125560*PED	2019-09-01		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020844-002	7125560	2019-03-01	U-766		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020844-002	7125560*PED	2019-09-01		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020844-003	7125560	2019-03-01	U-766		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020844-003	7125560*PED	2019-09-01		Pediatric extension	`ea99ee380514…`

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 6 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	2025-01-30	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	521be3f1-3ee7-45c7-9f0c-17e08b6c8fca	2025-01-21	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	d63b64dd-b420-4283-9bac-92ba43c9f429	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	eca774cf-2e4e-7642-e053-2a95a90a847d	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	d8dff98f-185e-77ba-e053-2995a90aed2f	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	f16065c0-9949-9ac4-e053-2995a90a3b02	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	f781ada8-f90d-b233-e053-6394a90a87ff	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	2024-10-25		Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	8706a35d-5c39-4daf-b83a-65f3d630e043	2024-08-21	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	61390be3-7553-4cb5-b5da-7571ed7d4b17	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	ffaacad8-4594-45a8-b292-02a84cd0c35b	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	b353e7fb-b976-96d8-e053-2995a90a110a	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57016639-89fe-43ad-89c4-5e7a756dddec	2024-08-14		Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	654f7c48-8c5d-4b97-88d6-397696f82b6a	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	1ef1c408-30f7-51ee-e063-6394a90ac880	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	e9cb3c29-098c-405f-a200-b436ac7fa1a2	2024-07-24	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	4a656a9f-8eb8-69b7-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	9ddb8451-a455-87ec-e053-2995a90a5e5e	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	816566bf-b909-606f-e053-2a91aa0ab8c9	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	87dc077b-2c84-522b-e053-2995a90a68bc	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-645	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-647	Topamax	topiramate	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85327	SUPPL	2026-03-12
85295	SUPPL	2026-03-09
85351	SUPPL	2026-03-06
81589	SUPPL	2025-03-17
81557	SUPPL	2025-03-14
74176	SUPPL	2023-05-04
74175	SUPPL	2023-05-04
74155	SUPPL	2023-05-02
72440	SUPPL	2022-10-21
69915	SUPPL	2022-01-19
69914	SUPPL	2022-01-19
69903	SUPPL	2022-01-19
69902	SUPPL	2022-01-19
68003	SUPPL	2021-07-01
68001	SUPPL	2021-07-01
68000	SUPPL	2021-07-01
63472	SUPPL	2020-06-09
63471	SUPPL	2020-06-09
63462	SUPPL	2020-06-09
58554	SUPPL	2019-05-03
58542	SUPPL	2019-05-03
58539	SUPPL	2019-05-03
57104	SUPPL	2019-01-02
57058	SUPPL	2018-12-30
57045	SUPPL	2018-12-28
54730	SUPPL	2018-06-29
54646	SUPPL	2018-06-21
48410	SUPPL	2017-05-17
48379	SUPPL	2017-05-16
26043	SUPPL	2014-12-19
13605	SUPPL	2014-12-19
13604	SUPPL	2014-10-23
3565	SUPPL	2014-10-23
26042	SUPPL	2014-04-02
13602	SUPPL	2014-04-01
13603	SUPPL	2014-01-31
3564	SUPPL	2014-01-30
3563	SUPPL	2012-11-01
35504	SUPPL	2012-10-29
3562	SUPPL	2011-07-19
13601	SUPPL	2011-07-18
3561	SUPPL	2011-03-08
13600	SUPPL	2011-03-04
35502	SUPPL	2010-01-04
35501	SUPPL	2010-01-04
35499	SUPPL	2010-01-04
13598	SUPPL	2010-01-04
26040	SUPPL	2009-12-30
26039	SUPPL	2009-12-30
3558	SUPPL	2009-12-30
3550	SUPPL	2009-12-30
35503	SUPPL	2009-05-12
13599	SUPPL	2009-05-12
26041	SUPPL	2009-05-04
3560	SUPPL	2009-05-04
13597	SUPPL	2009-04-28
3559	SUPPL	2009-04-27
26038	SUPPL	2006-10-23
26037	SUPPL	2005-07-08
26034	SUPPL	2005-07-08
13596	SUPPL	2005-07-05
13594	SUPPL	2005-07-05
21013	ORIG	2004-09-15
21015	SUPPL	2004-09-08
26035	SUPPL	2004-08-12
13595	SUPPL	2004-08-12
3557	SUPPL	2004-08-12
26032	SUPPL	2004-06-28
35500	SUPPL	2003-12-29
13593	SUPPL	2003-12-29
13592	SUPPL	2003-12-29
3554	SUPPL	2003-12-19
3553	SUPPL	2003-12-19
26036	SUPPL	2003-07-30
3556	SUPPL	2003-07-30
3555	SUPPL	2003-06-22
3551	SUPPL	2003-06-08
3552	SUPPL	2002-11-26
35498	SUPPL	2001-08-28
26033	SUPPL	2001-08-28
41758	SUPPL	2000-07-03
21014	SUPPL	2000-07-03
13591	SUPPL	1999-07-23
3549	SUPPL	1999-07-23
13590	ORIG	1998-10-26
3548	ORIG	1998-10-26
53032	ORIG	1900-01-01
53031	ORIG	1900-01-01