Application 211504

Type: ANDA
Sponsor: GLAND PHARMA LTD

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 1.

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
A211504-001	METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP		2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211504-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211504-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2018-10-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211504-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211504-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211504-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211504-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211504-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211504-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211504-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211504-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211504-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211504-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211504-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211504-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211504-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211504-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211504-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211504-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211504-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211504-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211504-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211504-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211504-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211504-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211504-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211504-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211504-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211504-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211504-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211504-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211504-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211504-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211504-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211504-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211504-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211504-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211504-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211504-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211504-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211504-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211504-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211504-001	AP	1	`cb3db0bc1861…`

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 1 of 1 · 5 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	Exact identifier application applno (ANDA): 211504 application number: ANDA211504
Methocarbamol	METHOCARBAMOL	Sagent Pharmaceuticals	01e7e2c7-49eb-4afb-a496-f2bd901622e9	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504
Methocarbamol	METHOCARBAMOL	Gland Pharma Limited	44c7fe99-8999-4747-9376-f13d3f9e5688	2020-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504 ndc (product): 68083-317
Methocarbamol	METHOCARBAMOL	Meitheal Pharmaceuticals Inc.	b60000fc-e99b-4994-9d36-3907e0da9e06	2019-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504 ndc (product): 71288-716
Methocarbamol	METHOCARBAMOL	Dr.Reddys Laboratories Inc.,	c88898af-5cd8-7bed-a03e-2ab4488e2040	2018-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211504 application number: ANDA211504 ndc (product): 43598-839

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-839	Methocarbamol	Methocarbamol	Dr.Reddy	ANDA	Current
68083-317	Methocarbamol	Methocarbamol	Gland Pharma Limited	ANDA	Current
68083-317	Methocarbamol	Methocarbamol	Gland Pharma Limited	ANDA	Current
70860-653	Methocarbamol	methocarbamol	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71288-716	Methocarbamol	Methocarbamol	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-716	Methocarbamol	Methocarbamol	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-716	Methocarbamol	Methocarbamol	Meitheal Pharmaceuticals Inc.	ANDA	Current