Application 215065

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

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 42.

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
A215065-001	METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV			2022-07-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2022-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2022-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2022-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV	AP	2022-07-14	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215065-001	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION / IM-IV		2022-07-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A215065-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215065-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215065-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215065-001	AP	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
methocarbamol	METHOCARBAMOL	Baxter Healthcare Corporation	a7f70b19-75ba-4e3d-b4fe-277fe7305bf0	2020-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215065 application number: ANDA215065 ndc (product): 36000-302

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
36000-302	methocarbamol	methocarbamol	Baxter Healthcare Corporation	ANDA	Current