Application 040823

Type: ANDA
Sponsor: NOVAST LABS

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 42.

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
A040823-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2008-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040823-001	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 · 42 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	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040823-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2008-10-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A040823-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040823-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040823-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040823-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040823-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040823-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040823-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040823-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040823-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040823-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040823-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040823-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040823-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040823-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040823-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040823-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040823-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040823-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040823-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040823-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040823-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040823-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040823-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040823-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040823-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040823-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040823-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040823-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040823-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040823-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040823-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040823-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040823-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040823-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040823-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040823-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040823-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040823-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040823-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040823-001	AA	1	`e64feba35796…`

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	Ingenus Pharmaceuticals, LLC	5eff5b4c-c363-45b5-9eef-b724233a51e2	2023-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040823 application number: ANDA040823 ndc (product): 50742-656

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-088	CARISOPRODOL	CARISOPRODOL	Blenheim Pharmacal, Inc.	ANDA	Current
33358-064	CARISOPRODOL	CARISOPRODOL	RxChange Co.	ANDA	Current
50090-3048	CARISOPRODOL	CARISOPRODOL	A-S Medication Solutions	ANDA	Current
50090-3048	CARISOPRODOL	CARISOPRODOL	A-S Medication Solutions	ANDA	Current
50090-3048	CARISOPRODOL	CARISOPRODOL	A-S Medication Solutions	ANDA	Current
50742-656	CARISOPRODOL	CARISOPRODOL	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-656	CARISOPRODOL	CARISOPRODOL	Ingenus Pharmaceuticals, LLC	ANDA	Current
55700-451	CARISOPRODOL	CARISOPRODOL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-451	CARISOPRODOL	CARISOPRODOL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-451	CARISOPRODOL	CARISOPRODOL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-768	CARISOPRODOL	CARISOPRODOL	DIRECT RX	ANDA	Current
61919-768	CARISOPRODOL	CARISOPRODOL	Direct_Rx	ANDA	Current
61919-768	CARISOPRODOL	CARISOPRODOL	Direct_Rx	ANDA	Current
61919-768	CARISOPRODOL	CARISOPRODOL	Direct_Rx	ANDA	Current
61919-768	CARISOPRODOL	CARISOPRODOL	Direct_Rx	ANDA	Current
64980-174	CARISOPRODOL	CARISOPRODOL	Rising Pharmaceuticals, Inc.	ANDA	Current
66267-043	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-043	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-043	CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-923	CARISOPRODOL	CARISOPRODOL	Contract Pharmacy Services-PA	ANDA	Current
67046-923	CARISOPRODOL	CARISOPRODOL	Contract Pharmacy Services-PA	ANDA	Current
67296-1602	CARISOPRODOL	CARISOPRODOL	RedPharm Drug, Inc.	ANDA	Current
67296-1602	CARISOPRODOL	CARISOPRODOL	RedPharm Drug, Inc.	ANDA	Current
68788-9976	CARISOPRODOL	CARISOPRODOL	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-0516	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current
71335-0516	CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	ANDA	Current