Application 088647

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	TABLET;ORAL	750MG	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
A088647-001	METHOCARBAMOL	METHOCARBAMOL	750MG	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	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088647-001	METHOCARBAMOL	750MG	TABLET / ORAL	1984-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088647-001	METHOCARBAMOL	750MG	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 9 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	201205d1-22f2-46bb-b298-02d4978ba568	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	27c39343-44e0-4ca6-a67f-1e6d11dd6799	2021-11-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Camber Pharmaceuticals, Inc.	43af0c41-9990-4902-9384-75de5ea08283	2021-04-06	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	39b4362e-a26e-49cb-9d06-898bc9b0e005	2021-04-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Sagent Pharmaceuticals	bc925726-4949-4647-bce8-e1180d36abe4	2021-03-12	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	75b964b7-3e76-4460-9777-7656b5daa32e	2020-12-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarb 500-EZS	METHOCARBAMOL	PureTek Corporation	383ce408-1085-43e7-944e-957ff2a9d553	2020-11-10	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
methocarbamol	METHOCARBAMOL	Baxter Healthcare Corporation	a7f70b19-75ba-4e3d-b4fe-277fe7305bf0	2020-09-28	Warnings, Adverse reactions	Name fallback brand name: methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	0003eccd-6147-4a7c-ae83-b2a94933e07d	2020-08-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Gland Pharma Limited	44c7fe99-8999-4747-9376-f13d3f9e5688	2020-07-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Meitheal Pharmaceuticals Inc.	b60000fc-e99b-4994-9d36-3907e0da9e06	2019-12-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Dr.Reddys Laboratories Inc.,	c88898af-5cd8-7bed-a03e-2ab4488e2040	2018-11-30	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Aphena Pharma Solutions - Tennessee, LLC	d825e4d6-8b00-473a-a6e6-90f5c3ad5bec	2018-10-24	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Aphena Pharma Solutions - Tennessee, LLC	3757cd8e-6054-4b75-bb04-d11f34c65cbe	2018-09-12	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol

Reported adverse events (FAERS/openFDA)#

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