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 8 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL TABLETS	Pharmasource Meds, LLC	f43a9389-c641-ce49-e053-2a95a90a537f	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	1880efb2-b97e-1e4d-e063-6294a90ab3e3	2024-05-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
ROBAXIN	METHOCARBAMOL	Hikma Pharmaceuticals USA Inc.	090a3d3d-92c3-4c30-a648-436461f81702	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
ROBAXIN	METHOCARBAMOL	Hikma Pharmaceuticals USA Inc.	a418c43a-afe8-4a19-a57a-95c8dbe3d3d8	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Medsource Pharmaceuticals	127583d4-7963-bd6d-e063-6294a90ab73e	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	1637e18d-d9f9-4171-99e6-4b866d821c87	2024-02-07	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	XLCare Pharmaceuticals Inc.	f8bfb5cb-b7d0-4e09-b6bd-97a51d82c991	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	8cf27774-82ed-4ed1-a55d-41bf476745db	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Aurobindo Pharma Limited	f83dd093-ea53-44c1-a40d-682ebc494b62	2024-01-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	2c1f5949-d771-45c6-8d8a-5e1942c853dc	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	6155b45d-3ad3-4ca4-a6ee-42885414c0e1	2023-10-17	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Eugia US LLC	e8e8da30-64cf-42ea-bf71-d085b0be8a09	2023-10-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	d8e3f8dc-9751-419b-8601-d85c43415c82	2023-09-21	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	f1bce76f-4c3a-40d2-8107-afc0d3a6ba19	2023-05-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	4003026f-ed9e-40ac-9e7e-5e28d32d7cb8	2023-05-26	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	b415184c-1603-4a86-92d2-746f8d3d3f3c	2023-03-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	d217bd1d-0b6e-4a4c-a47b-de73b94e8b13	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	c40d5c1d-9bd8-44aa-85a4-e1a34e1d3673	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	10ae354f-94a4-4d4e-bccc-ea189726b7ce	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Proficient Rx LP	f6193255-0e83-4510-bc86-30c926ee8fd1	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol

Reported adverse events (FAERS/openFDA)#

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