Application 207496

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOCARBAMOL	METHOCARBAMOL	SOLUTION;IM-IV	1GM/10ML (100MG/ML)	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
A207496-001	METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP		2017-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207496-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207496-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2017-06-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207496-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207496-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207496-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207496-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207496-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207496-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207496-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207496-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207496-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207496-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207496-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207496-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207496-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207496-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207496-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207496-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207496-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207496-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207496-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207496-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207496-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207496-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207496-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207496-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207496-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207496-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207496-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207496-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207496-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207496-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207496-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207496-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207496-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207496-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207496-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207496-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207496-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207496-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207496-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207496-001	AP	1	`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 5 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Marlex Pharmaceuticals, Inc.	d2e38ac9-1cf3-14ca-e053-2a95a90a8522	2025-11-21	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Oncora Pharma, LLC	440d6c99-8aca-af07-e063-6294a90aee3d	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PHOENIX RX LLC	39bc9ecf-837e-5bb8-e063-6394a90a917e	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
METHOCARBAMOL	METHOCARBAMOL	Henry Schein, Inc	d48d76af-b55a-4908-95ff-e7de615c0513	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: METHOCARBAMOL generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	9aed8304-fa4e-49d6-bd81-fcb3e4cc6173	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	PHOENIX RX LLC	414b2fe0-fa2b-2b18-e063-6394a90ab2b9	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	ff55df39-e314-4120-8fab-3757cbe5a872	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	069045f1-d699-41d0-b674-cdb71cd5fbd0	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	f7ab7f11-9b5a-4d3a-a8fc-eee55b1fc006	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	fdea0332-1ad8-40ef-8cb9-b3c46588155d	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Sagent Pharmaceuticals	01e7e2c7-49eb-4afb-a496-f2bd901622e9	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Solco Healthcare LLC	32863f21-30ff-4a8b-a2e6-8ab14a37af0d	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6ca768bf-5095-4148-82d2-a0c2dec16d87	2025-09-16	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	Bryant Ranch Prepack	dfb0e2ee-fd87-4100-9d44-f7a091e73a6c	2025-09-12	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Doc Rx	5e55526f-bb34-4b67-85ea-b2765e8066bb	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PHOENIX RX LLC	3b199152-bafc-e14a-e063-6394a90ab283	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	f07c0a35-fb5d-43a1-a33e-d6a51a5fcd77	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	A-S Medication Solutions	5f746f0f-e884-46d9-a104-529293b0fb90	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	A-S Medication Solutions	ff572473-90e3-4f3b-a40e-8b97b86d327b	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol Tablets, USP, 500 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	6500c6eb-fa1e-46a5-839f-13047e107e97	2025-07-08	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-1825	Methocarbamol	methocarbamol	American Regent, Inc.	ANDA	Current
0517-1825	Methocarbamol	methocarbamol	American Regent, Inc.	ANDA	Current
0517-1825	Methocarbamol	methocarbamol	American Regent, Inc.	ANDA	Current
51662-1435	METHOCARBAMOL	METHOCARBAMOL	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1435	METHOCARBAMOL	METHOCARBAMOL	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current