Application 215721

Type: NDA
Sponsor: ALMATICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	CAPSULE;ORAL	7.5MG	Yes	Yes

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
N215721-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL	AB	RLD, RS	2023-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N215721-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL		RLD, RS	2023-05-09	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215721-001	ZOLPIDEM TARTRATE	7.5MG	CAPSULE / ORAL	AB	RLD, RS	2023-05-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215721-001	AB	1	`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
zolpidem tartrate	ZOLPIDEM TARTRATE	Almatica Pharma LLC	2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215721 application number: NDA215721

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77881	ORIG	2024-03-20
74221	ORIG	2023-05-11
74212	ORIG	2023-05-10
74211	ORIG	2023-05-10