Application 090988

Type: ANDA
Sponsor: NATCO PHARMA 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
A090988-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2014-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090988-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090988-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2014-10-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090988-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090988-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090988-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090988-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090988-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090988-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090988-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090988-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090988-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090988-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090988-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090988-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090988-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090988-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090988-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090988-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090988-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090988-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090988-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090988-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090988-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090988-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090988-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090988-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090988-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090988-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090988-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090988-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090988-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090988-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090988-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090988-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090988-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090988-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090988-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090988-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090988-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090988-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090988-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090988-001	AA	1	`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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carisoprodol	CARISOPRODOL	Mylan Pharmaceuticals Inc.	7c9184c0-7a2e-11df-8c8d-0002a5d5c51b	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mg	CARISOPRODOL	Granulation Technology, Inc.	2abd11e4-8ce4-4aeb-87c4-3af94c197714	2025-06-11	Warnings, Adverse reactions	Name fallback generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	4626a7a7-c433-4dab-8deb-e6e45de493a6	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	9d251c26-c893-425a-b8ac-20c06e50e80c	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	fd03c357-b199-c2b2-e053-6294a90abe2e	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	f8aee817-c652-441e-b99a-8cbc4e6d06ef	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	95e13b8c-3558-43f0-b888-90978db878fb	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	acc7f959-55ac-4d9b-8ef4-4538378364e6	2025-01-24	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Direct_Rx	ead8294f-fd27-5c3d-e053-2a95a90a64af	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Advanced Rx Pharmacy of Tennessee, LLC	f835e66e-f3f3-c3cf-e053-6294a90addf2	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Oxford Pharmaceuticals, LLC	03c3455f-e217-4a7e-908f-609333dc35fc	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Wilshire Pharmaceuticals, Inc.	f03a1ea6-20c1-406a-a5b6-00f1a056d9ff	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	Asclemed USA, Inc.	301f5e6a-54e1-4885-b9cb-de475de59b22	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	Bryant Ranch Prepack	fdd6318f-399f-499c-acdc-5318aa080f36	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	b72ac75b-8c7c-4ec4-a7fa-b9c1a18f644c	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: carisoprodol generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	8079db44-70d4-4daf-b4b7-89d0e0f38470	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
CARISOPRODOL	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	93cbe188-5443-b392-e053-2995a90a9ac7	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: CARISOPRODOL generic name: CARISOPRODOL
Carisoprodol	CARISOPRODOL	Medsource Pharmaceuticals	125023cb-45c2-1685-e063-6394a90af089	2024-02-26	Warnings, Adverse reactions	Name fallback brand name: Carisoprodol generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	Aurobindo Pharma Limited	79637c7b-fe7b-436c-892b-6c36abfdcacc	2024-01-06	Warnings, Adverse reactions	Name fallback brand name: carisoprodol generic name: CARISOPRODOL
carisoprodol	CARISOPRODOL	Rising Pharma Holdings, Inc.	4d2470cb-7a5d-45f0-b005-534458833d91	2024-01-06	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.