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 1 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
2026-09-14 22:38:34	2026-08	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040320-001	TAPAZOLE	5MG	TABLET / ORAL		2000-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040320-002	TAPAZOLE	10MG	TABLET / ORAL		2000-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040320-001	TAPAZOLE	5MG	TABLET / ORAL	AB	2000-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040320-002	TAPAZOLE	10MG	TABLET / ORAL	AB	2000-03-31	`74a2ff9319b5…`

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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	f74a8e69-79a1-4061-b42f-447e0780c04f	2025-05-13	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	94d2e57b-685f-4cfd-a5a5-129e869c794c	2025-04-24	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	a86f51a6-1ab8-48c2-a4fc-2439e9986d45	2025-04-24	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Rising Pharma Holdings, Inc.	289ec852-176e-41aa-9f9a-b1f9b4196771	2025-03-06	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	American Health Packaging	ca252851-32f2-4eb9-b9f5-82029f0e8c20	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	d003a93d-da08-4993-bb72-700342ca6e65	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Golden State Medical Supply, Inc.	4eff3321-2fce-4bab-94af-7b16e333beed	2024-09-24	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	NORTHSTAR RX LLC	923fec30-90fd-4bd5-beb3-f2ca4fc171ee	2024-06-28	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Upsher-Smith Laboratories, LLC	2185e6e0-7c21-4348-a7b4-d898f50a0184	2024-03-22	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bionpharma Inc.	141a91d5-b56e-06d6-e063-6394a90a11ba	2024-03-20	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	e03d32dd-878f-43ee-b8c2-3adad98bf66c	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
methimazole	METHIMAZOLE	SQUARE PHARMACEUTICALS PLC.	33e065a1-dd4e-43f9-a841-f96e633fc850	2024-02-20	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	381052c4-891c-4ae4-b63e-65229126cbca	2023-11-10	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	3ca961ca-cbf2-4a73-8c81-4205e01b2695	2023-11-08	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	A-S Medication Solutions	87eb663e-5dd3-4a7a-8b28-7e19c5ad1173	2023-06-29	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	c511344b-cc7f-499b-bb21-5b2312ff311e	2023-02-20	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	6bdf42f6-0ce6-4e05-8962-0019fc7c65a2	2023-02-17	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Strides Pharma Science Limited	0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f	2022-04-22	Warnings, Adverse reactions	Name fallback generic name: METHIMAZOLE
Methimazole	METHIMAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8c3a9aaa-cdde-404b-9af6-5a88ef649aac	2022-03-24	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