Application 040755

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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 43.

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
A040755-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL			2007-02-27

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040755-001	CARISOPRODOL	350MG	TABLET / ORAL	2007-02-27	`f41ea6bd6efb…`

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 3 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carisoprodol	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	2484de44-b36a-421c-a4d9-64c201694754	2023-12-11	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Asclemed USA, Inc.	4221d7d1-d7d6-46c4-be41-8c8e99129324	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Ingenus Pharmaceuticals, LLC	5eff5b4c-c363-45b5-9eef-b724233a51e2	2023-01-02	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Proficient Rx LP	b04fbd67-9ac5-4043-87e9-c3804d1e5d0c	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	2178e805-8189-459f-a447-21bf1547744a	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	2179f18b-df15-4bf6-a7c7-6d9960f49a42	2021-12-13	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Proficient Rx LP	efd7a0b4-5ec5-4929-a4cb-7d207171eed6	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Vensun Pharmaceuticals, Inc.	7c6015ad-2158-400d-8c22-585ab277ea49	2018-11-08	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-068	Carisoprodol	Carisoprodol	Rebel Distributors Corp	ANDA	Current
45865-408	Carisoprodol	Carisoprodol	Medsource Pharmaceuticals	ANDA	Current
50090-0280	Carisoprodol	Carisoprodol	A-S Medication Solutions	ANDA	Current
50090-0281	Carisoprodol	Carisoprodol	A-S Medication Solutions	ANDA	Current
50436-3435	Carisoprodol	Carisoprodol	Unit Dose Services	ANDA	Current
51655-376	Carisoprodol	Carisoprodol	Northwind Pharmaceuticals	ANDA	Current
61919-039	CARISOPRODOL	CARISOPRODOL	Direct Rx	ANDA	Current
62756-446	Carisoprodol	Carisoprodol	Sun Pharmaceutical Indust	ANDA	Current
63187-113	Carisoprodol	Carisoprodol	Proficient Rx LP	ANDA	Current
66267-767	Carisoprodol	Carisoprodol	NuCare Pharmaceuticals, Inc.	ANDA	Current
67296-1222	Carisoprodol	Carisoprodol	RedPharm Drug, Inc.	ANDA	Current
71335-0407	Carisoprodol	Carisoprodol	Bryant Ranch Prepack	ANDA	Current