Application 011792

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOMA	CARISOPRODOL	TABLET;ORAL	350MG	Yes	No
003	SOMA	CARISOPRODOL	CAPSULE;ORAL	250MG	Yes	No
004	SOMA	CARISOPRODOL	TABLET;ORAL	250MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011792-001	SOMA	CARISOPRODOL	350MG	TABLET / ORAL	AA	RLD, Approved before 1982
N011792-003	SOMA	CARISOPRODOL	250MG	CAPSULE / ORAL		RLD, Approved before 1982
N011792-004	SOMA	CARISOPRODOL	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011792-001	AA
N011792-004	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011792-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011792-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011792-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011792-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011792-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011792-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011792-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011792-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011792-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011792-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011792-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011792-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011792-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011792-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011792-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011792-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011792-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011792-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011792-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011792-004	AB	1	`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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Soma	CARISOPRODOL	Viatris Specialty LLC	6297cf20-830a-11dc-94c8-0002a5d5c51b	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011792 application number: NDA011792 ndc (product): 0037-2001 ndc (product): 0037-2250
Carisoprodol	CARISOPRODOL	Mylan Pharmaceuticals Inc.	7c9184c0-7a2e-11df-8c8d-0002a5d5c51b	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011792 application number: NDA011792 ndc (product): 51525-5901

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-2001	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2001	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2001	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2001	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2250	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2250	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2250	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
0037-2250	Soma	Carisoprodol	Meda Pharmaceuticals	NDA	Current
21695-606	Soma	Carisoprodol	Rebel Distributors Corp	NDA	Current
51525-5901	Carisoprodol	carisoprodol	Wallace Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
51525-5901	Carisoprodol	carisoprodol	Wallace Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
51525-5901	Carisoprodol	carisoprodol	Wallace Pharmaceuticals I	NDA AUTHORIZED	Current
51525-5901	Carisoprodol	carisoprodol	Wallace Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58232	SUPPL	2019-04-05
58223	SUPPL	2019-04-05
55272	SUPPL	2018-08-23
11962	SUPPL	2015-02-25
33058	SUPPL	2013-02-06
287	SUPPL	2013-02-04
20030	SUPPL	2012-11-16
11961	SUPPL	2010-01-06
33057	SUPPL	2009-11-17
11960	SUPPL	2007-09-25
33056	SUPPL	2007-09-19
10780	SUPPL	2006-06-12
286	SUPPL	2006-06-12