Application 040320

Type: ANDA
Sponsor: KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAPAZOLE	METHIMAZOLE	TABLET;ORAL	5MG	No	No
002	TAPAZOLE	METHIMAZOLE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040320-001	TAPAZOLE	METHIMAZOLE	5MG	TABLET / ORAL			2000-03-31
A040320-002	TAPAZOLE	METHIMAZOLE	10MG	TABLET / ORAL			2000-03-31

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 2 of 3 · 86 observed 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
2022-03-09 01:35 UTC	2022-03	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040320-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040320-002	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A040320-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040320-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040320-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040320-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040320-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040320-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040320-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040320-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040320-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040320-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040320-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040320-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040320-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040320-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040320-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040320-002	AB	1	`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 1 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	f69edfa9-0efb-4fe8-aeab-50f7baeebb6a	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	AiPing Pharmaceutical, Inc.	06bb4bcc-5e47-48b6-a76c-648f846704e8	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	b53f84ac-4263-478c-883d-aca7ab44fef5	2026-07-07	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	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

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60793-104	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-104	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-104	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-104	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-105	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-105	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-105	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current
60793-105	TAPAZOLE	methimazole	Pfizer Laboratories Div Pfizer Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17769	SUPPL	2012-07-25
7624	ORIG	2000-03-31