Application 205126

Type: ANDA
Sponsor: WILSHIRE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARISOPRODOL	CARISOPRODOL	TABLET;ORAL	250MG	No	No
002	CARISOPRODOL	CARISOPRODOL	TABLET;ORAL	350MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205126-001	CARISOPRODOL	CARISOPRODOL	250MG	TABLET / ORAL	AB		2015-07-08
A205126-002	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2015-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205126-001	AB
A205126-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205126-001	CARISOPRODOL	250MG	TABLET / ORAL	AB	2015-07-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205126-002	CARISOPRODOL	350MG	TABLET / ORAL	AA	2015-07-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205126-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205126-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205126-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205126-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205126-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205126-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205126-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205126-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205126-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205126-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205126-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205126-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205126-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205126-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205126-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205126-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205126-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205126-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205126-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205126-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205126-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205126-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205126-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205126-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205126-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205126-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205126-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205126-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205126-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205126-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205126-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205126-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205126-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205126-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205126-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205126-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205126-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205126-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205126-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205126-002	AA	1	`bb7c543d1eb4…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carisoprodol	CARISOPRODOL	Wilshire Pharmaceuticals, Inc.	f03a1ea6-20c1-406a-a5b6-00f1a056d9ff	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205126 application number: ANDA205126 ndc (product): 52536-688 ndc (product): 52536-682

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52536-682	Carisoprodol	Carisoprodol	Wilshire Pharmaceuticals, Inc.	ANDA	Current
52536-682	Carisoprodol	Carisoprodol	Wilshire Pharmaceuticals, Inc.	ANDA	Current
52536-688	Carisoprodol	Carisoprodol	Wilshire Pharmaceuticals, Inc.	ANDA	Current
52536-688	Carisoprodol	Carisoprodol	Wilshire Pharmaceuticals, Inc.	ANDA	Current