Application 084471

Type: ANDA
Sponsor: PURACAP PHARM

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
A084471-001	METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084471-001	METHOCARBAMOL	750MG	TABLET / ORAL	Approved before 1982	`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 7 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	afc9d84d-c8dd-05c0-e053-2a95a90a22a2	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	af73ae4b-bcf5-2e21-e053-2a95a90a2dce	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	c06c4a63-491c-baa2-e053-2a95a90a09ff	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	c9600cc9-7e27-6e19-e053-2995a90ab024	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	f4e98f9f-b20b-8608-e053-2a95a90aa6b0	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx Pharmacy of Tennessee, LLC	f6567e04-12f0-fa79-e053-2995a90a9a0e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	8c18ffef-b2c5-4af2-af66-e22c168e7680	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Key Therapeutics	a88a6c84-b55a-4b6b-ac01-554079f6e304	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Key Therapeutics	cf931001-95bd-4900-98d5-f5ef54b49d99	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Fresenius Kabi USA, LLC	bdf17640-221c-4c80-b48c-101daaece1d6	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	3f47c39b-9373-454f-9a4e-ba6dd65dd7a4	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	add9e47f-11ac-e10d-bfc2-b9c52aa08fa5	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals,Inc.	9d6024b2-ee1a-3a79-e053-2a95a90a1bf4	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals, Inc.	3e89a426-c741-2f44-e054-00144ff8d46c	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	NCS HealthCare of KY, LLC dba Vangard Labs	32ea8117-4a35-4e2c-93bc-866544b2c3be	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	47d8f1c7-8395-48e0-ac6f-d35dadfb7a50	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Tanlor	METHOCARBAMOL	Forte Bio-Pharma	1dd5f7fd-7b3b-8669-e063-6394a90abe95	2024-07-22	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	NuCare Pharmaceuticals, Inc.	1c368c79-ac60-bfa7-e063-6394a90a9ff7	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
methocarbamol	METHOCARBAMOL	Slate Run Pharmaceuticals, LLC	bc16295e-f3aa-4ed5-9fd6-ac4c750e0bba	2024-06-24	Warnings, Adverse reactions	Name fallback brand name: methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Asclemed USA, Inc.	5a9b1104-4c9a-4c8c-9e24-719a7b3a89d7	2024-06-13	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.