Application 088646

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	500MG	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
A088646-001	METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET / ORAL			1984-02-29

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	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088646-001	METHOCARBAMOL	500MG	TABLET / ORAL	1984-02-29	`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 6 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	fe872a3a-fb14-4a0a-b9e4-c9f1885b4978	2025-06-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Granulation Technology, Inc.	70c5342c-9597-4fe6-863c-f8ae4adc063a	2025-06-10	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Golden State Medical Supply, Inc.	c67d3e2b-92cd-1b97-e053-2a95a90af36f	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9357672f-5d4d-40f5-a304-e0c34e174dc3	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	43ea5baa-4200-47ff-8819-44c802cba977	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
METHOCARBAMOL	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	5a48be27-5069-40f3-85de-86f248ae232f	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: METHOCARBAMOL generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	GENTEX PHARMA, LLC	35c044a6-90c0-55f8-e063-6294a90aad48	2025-05-22	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	9169399e-bca1-4c44-9a93-886f3650e44d	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol Tablets, USP, 750 mg	METHOCARBAMOL	Bryant Ranch Prepack	3d686023-a4a2-4dae-8bfb-1f6b01ca24f0	2025-05-05	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	38d8b457-0c0f-45cb-bf90-965c5a01b198	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	2a99a422-6bad-4316-90bc-e7c2d1e3fb53	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Somerset Therapeutics, LLC	68dd9c24-4d41-48be-9f54-fceb787bb443	2025-03-22	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Trifluent Pharma LLC	de2e3af9-03ab-4dc8-b480-6866474ad1bd	2025-03-03	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Preferred Pharmaceuticals Inc.	eed9ebd1-c243-4e82-bf4e-5fec370e722e	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
methocarbamol	METHOCARBAMOL	FH2 PHARMA LLC	1dd56e3d-7ca7-1443-e063-6294a90a13c5	2025-02-06	Warnings, Adverse reactions	Name fallback brand name: methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Coupler LLC	2cee3893-70b7-6c2c-e063-6394a90aa79a	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	2cf76cdc-820d-1c5b-e063-6294a90a35aa	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Asclemed USA, Inc.	edbcf8c6-0df8-4e72-885b-16d378f06c7b	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Redpharm Drug, Inc.	09d22ef9-a472-4db9-e063-6394a90a8870	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
METHOCARBAMOL	METHOCARBAMOL	DirectRx	ceb428e0-d6e4-57b7-e053-2995a90afcda	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: METHOCARBAMOL generic name: METHOCARBAMOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.