Application 214925

Type: ANDA
Sponsor: MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIMAVANSERIN	PIMAVANSERIN	CAPSULE; ORAL	34MG	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
A214925-001	PIMAVANSERIN	PIMAVANSERIN TARTRATE	EQ 34MG BASE	CAPSULE / ORAL			2024-01-16

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	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL	AB	2024-01-16	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214925-001	PIMAVANSERIN	EQ 34MG BASE	CAPSULE / ORAL		2024-01-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A214925-001	AB	1	`1c564ffb4f44…`

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
pimavanserin	PIMAVANSERIN	Novadoz Pharmaceuticals LLC	403b6540-c53d-4e92-91b4-36ca6338b2b1	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214925 application number: ANDA214925

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71684	ORIG	2022-08-01