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 3 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methocarbamol	METHOCARBAMOL	JVET PHARMACEUTICALS LLC	d9e4748f-11c5-4d87-b260-1be94febe806	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	St. Mary's Medical Park Pharmacy	faa81ad3-2bd2-d637-e053-6294a90a2d36	2026-05-10	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL TABLETS	Proficient Rx LP	23163bc1-dec7-41f6-baed-eedebfd6be7e	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Redpharm Drug	44f2aa92-4619-021e-e063-6394a90a296c	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Sportpharm LLC	64a06ef2-a062-49cc-9526-03c22b6ced2c	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Advanced Rx of Tennessee, LLC	4de118fe-bd8e-6cc4-e063-6394a90a1320	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol Tablets, USP, 750 mg	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Doc Rx	f4956165-3605-4ff3-9fd1-70157edc08ca	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Misemer Pharmaceutical	e89ae224-ed25-4ae7-e053-2a95a90a9c0e	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Oxford Pharmaceuticals, LLC	06dc72a6-ef3a-425a-9194-a9d228093cc4	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	b72a3fff-9710-4c60-8ca6-ed428377fc24	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
ATMEKSI	METHOCARBAMOL	Rosemont Pharmaceuticals LLC	62de7345-613b-4838-96e5-aceca3cea6b2	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Advanced Rx of Tennessee, LLC	4cefe51c-d824-a862-e063-6394a90a7717	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Bryant Ranch Prepack	d3448618-c9b4-4cb9-a30e-1afc8197cfe1	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	ASCLEMED USA INC.	077fa923-bee0-4b34-a52d-6f870bcb4828	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL TABLETS	Redpharm Drug	44f264fd-bf40-bed9-e063-6294a90ac44a	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol
Methocarbamol	METHOCARBAMOL	Proficient Rx LP	311c79a5-1447-4fef-8726-ae003ef64db5	2026-03-01	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	Advanced Rx of Tennessee, LLC	4b1d8ac6-d25d-1c37-e063-6394a90aba29	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	288a3bcd-a2c8-4a9b-9602-59c0493b4a8d	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Methocarbamol generic name: METHOCARBAMOL
Methocarbamol	METHOCARBAMOL	PD-Rx Pharmaceuticals, Inc.	3b0e60a7-3cff-4665-a473-ad3257619cdd	2026-02-16	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.

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