Application 219843

Type: NDA
Sponsor: ROSEMONT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATMEKSI	METHOCARBAMOL	SUSPENSION;ORAL	750MG/5ML	Yes	Yes
002	ATMEKSI	METHOCARBAMOL	SUSPENSION;ORAL	750MG(5ML)	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
N219843-001	ATMEKSI	METHOCARBAMOL	750MG/5ML	SUSPENSION / ORAL		RLD, RS	2025-07-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219843-001	12390439	2044-10-09	U-4253	Drug product	2025-08-19

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219843-001	ATMEKSI	750MG/5ML	SUSPENSION / ORAL	RLD, RS	2025-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219843-001	ATMEKSI	750MG/5ML	SUSPENSION / ORAL	RLD, RS	2025-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219843-001	ATMEKSI	750MG/5ML	SUSPENSION / ORAL	RLD, RS	2025-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219843-001	ATMEKSI	750MG/5ML	SUSPENSION / ORAL	RLD, RS	2025-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219843-001	ATMEKSI	750MG/5ML	SUSPENSION / ORAL	RLD, RS	2025-07-30	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219843-001	ATMEKSI	750MG/5ML	SUSPENSION / ORAL	RLD, RS	2025-07-30	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219843-001	12390439	2044-10-09	U-4253	Drug product	2025-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219843-001	12390439	2044-10-09	U-4253	Drug product	2025-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219843-001	12390439	2044-10-09	U-4253	Drug product	2025-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219843-001	12390439	2044-10-09	U-4253	Drug product	2025-08-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219843-001	12390439	2044-10-09	U-4253	Drug product	2025-08-19	`a50c72e98297…`

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
ATMEKSI	METHOCARBAMOL	Rosemont Pharmaceuticals LLC	62de7345-613b-4838-96e5-aceca3cea6b2	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219843 application number: NDA219843

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83011	ORIG	2025-08-01
83006	ORIG	2025-07-31