Application 007517

Type: NDA
Sponsor: KING PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TAPAZOLE	METHIMAZOLE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	TAPAZOLE	METHIMAZOLE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N007517-002	TAPAZOLE	METHIMAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N007517-004	TAPAZOLE	METHIMAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007517-002	TAPAZOLE	5MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N007517-004	TAPAZOLE	10MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007517-002	TAPAZOLE	5MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N007517-004	TAPAZOLE	10MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N007517-002	TAPAZOLE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N007517-004	TAPAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`

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 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	b53f84ac-4263-478c-883d-aca7ab44fef5	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b	2026-07-06	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	c1e6f1ee-238c-466e-b223-3c3f63dac9ed	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	244d76f1-98e6-4305-8768-b104f6a4be07	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	AvKARE	545381b6-e9e9-de1e-e063-6294a90a9a97	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Chartwell RX, LLC	5b25e346-11b6-44ed-89f9-ab927232ac19	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	AiPing Pharmaceutical, Inc.	06bb4bcc-5e47-48b6-a76c-648f846704e8	2026-02-07	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	253088bf-00f2-489b-984a-682ef9d89e90	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
methimazole	METHIMAZOLE	Coupler LLC	490f04db-cb51-bde7-e063-6394a90a5546	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
methimazole	METHIMAZOLE	Coupler LLC	490f168f-c703-5497-e063-6294a90ade87	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	afa2cecc-3fef-4372-8d1e-6bbb06d41b23	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	3f65518b-33da-48d8-9af2-2a750400b401	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	d05f7950-84cd-413f-9256-4c0977818d25	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	1f6970fb-a549-47b0-b812-48109521d713	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	AvPAK	4116774b-6c2b-2c74-e063-6394a90a4955	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Macleods Pharmaceuticals Limited	6f08df05-cc29-45ef-8f6e-12272bfbb0d7	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
methimazole	METHIMAZOLE	Viona Pharmaceuticals Inc.	05a8fed7-f805-4c59-8840-630174b6d130	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Proficient Rx LP	e921f23b-a9bf-4313-9cfa-f0b29c06f72a	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	f74a8e69-79a1-4061-b42f-447e0780c04f	2025-05-13	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10694	SUPPL	2009-03-13