Application 081025

Type: ANDA
Sponsor: FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARISOPRODOL	CARISOPRODOL	TABLET;ORAL	350MG	No	No

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

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
A081025-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		1989-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081025-001	AA

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL		1989-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL		1989-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL		1989-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL		1989-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL		1989-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081025-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1989-04-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A081025-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081025-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081025-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081025-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081025-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081025-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081025-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081025-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081025-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081025-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081025-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081025-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081025-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081025-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081025-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081025-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081025-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A081025-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081025-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081025-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081025-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081025-001	AA	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081025-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081025-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081025-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081025-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081025-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081025-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081025-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081025-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081025-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081025-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081025-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081025-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081025-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A081025-001	AA	1	`a50c72e98297…`

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 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	b83f7fd1-11e3-4e94-ae53-4637e892b372	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Northwind Health Company, LLC	26e466be-8066-e562-e063-6394a90a9f81	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	St. Mary's Medical Park Pharmacy	94f74800-1f0d-7814-e053-2a95a90a4f63	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	269644bf-d32c-48a3-b3eb-1221150ebd22	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	eebb9409-e333-4b9f-8059-6588c35ab578	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	59f6f0e3-fdbd-4788-9944-37edde4b9a3c	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	a3f1343f-1337-4b99-b1ae-4189324ec2e9	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	93f909ea-2d2e-4a10-be50-7f33f3e904d4	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Westminster Pharmaceuticals, LLC	bfb31551-8c57-4360-be3a-f6fbe84a891e	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Directrx	d5cc9f99-59ae-55db-e053-2995a90affb7	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	ScieGen Pharmaceuticals, Inc.	069ea892-21a6-4703-8dd3-bf19c4406479	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	6c15f559-c045-4271-86ef-e001aad39c33	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	88f9b969-4225-49d6-9e4c-8c397ba7b50c	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Direct_Rx	8e9bb49a-8cc3-4390-e053-2a95a90a4e0e	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Chartwell RX, LLC	a44a3dfc-a427-4584-a086-4bc0c538b125	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	Bryant Ranch Prepack	35a8e0a4-93a3-44e3-903f-4661ee1cffe8	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	Bryant Ranch Prepack	409b04af-b9fd-4ba5-afa0-3e43466f8d2d	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	1f08f4af-37c2-49b5-a4e3-284414f866fa	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Soma	CARISOPRODOL	Viatris Specialty LLC	6297cf20-830a-11dc-94c8-0002a5d5c51b	2025-08-29	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	8c0c418c-90e2-4b81-a9c0-b131c38ec874	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL