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 4 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	943fe701-5d7d-4abe-a529-c5a548e94bc6	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	440bf1ba-a704-4c35-bece-0a0987fc0c11	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	12c8da39-3a0e-4303-9655-29dd83507837	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PHOENIX RX LLC	4abc29e9-a0cc-06cf-e063-6294a90ad874	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Major Pharmaceuticals	2df34fa7-9cdc-4be4-ac6f-577122462606	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bostal LLC	d8f10211-f96e-4cf3-9b49-986eb51b703d	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	NuCare Pharmaceuticals,Inc.	72f36d28-15d2-30f6-e053-2a91aa0ad1ce	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	UNICHEM PHARMACEUTICALS (USA), INC.	5777cbb0-b5fd-4b36-ac1d-bc105fe96888	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Northwind Health Company, LLC	f2b4ed95-0469-393a-e053-2a95a90a98ed	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals,Inc.	36c2c31c-8648-7723-e063-6294a90aec98	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
METHOCARBAMOL	METHOCARBAMOL	DIRECT RX	31508051-c9cb-149b-e054-00144ff88e88	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: METHOCARBAMOL generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	AvPAK	be37bc85-6a41-00d8-e053-2a95a90ae504	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Northwind Health Company, LLC	f2b4ed5f-3489-9ee4-e053-2995a90a25f0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Northwind Health Company, LLC	f31ccb09-7a9a-60af-e053-2995a90a6e97	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Northwind Health Company, LLC	df63611f-90e4-6bbe-e053-2a95a90a2aad	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	e4ebe9cf-a274-47c7-b740-4b3d6e9dc52b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Redpharm Drug	46e983de-434e-7ff3-e063-6394a90aa466	2025-12-27	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	18810520-3040-4802-e063-6294a90a1ec0	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Granules India Ltd	42c0a177-7d62-4bcf-9fce-7dd484cda4d5	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	7f297ac6-a580-4539-a770-fe5d15c2b922	2025-11-24	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.