Application 022196

Type: NDA
Sponsor: AYTU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLPIMIST	ZOLPIDEM TARTRATE	SPRAY, METERED;ORAL	5MG/SPRAY	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022196-001	ZOLPIMIST	ZOLPIDEM TARTRATE	5MG/SPRAY	SPRAY, METERED / ORAL		RLD	2008-12-19

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
N022196-001	8236285	2032-08-07	U-70	Drug substance, Drug product

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD	2008-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022196-001	ZOLPIMIST	5MG/SPRAY	SPRAY, METERED / ORAL	RLD, RS	2008-12-19	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N022196-001	8236285	2032-08-07	U-70	Drug substance, Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022196-001	8236285	2032-08-07	U-70	Drug substance, Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022196-001	8236285	2032-08-07	U-70	Drug substance, Drug product	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022196-001	8236285	2032-08-07	U-70	Drug substance, Drug product	`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 6 · 114 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Torrent Pharmaceuticals Limited	1584bad1-7bf4-4805-bdd9-7eb0fac92721	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Breckenridge Pharmaceutical, Inc.	cbda91f7-4411-4016-80d6-0a349931956d	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	59cc61da-838e-4add-b2d6-42b2b283a000	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	413b6f65-101e-e2cf-0802-711d080b851b	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	2abdcf77-d3ed-42bc-acd9-545aab75d567	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	507225e2-80ba-18c4-e054-00144ff88e88	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	TORRENT PHARMACEUTICALS LIMITED	9025a6f7-5501-4aba-875e-222ef39848c0	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	90201886-86a5-4c59-a4f1-98270d620731	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	bf99cd5c-9671-45a6-bda9-3dfc8252efdd	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	89cfb1d5-437c-4c13-8f9b-b6851ffba87b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	cf3dcbde-b92a-4802-98e4-14f00abdf99e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	21767f56-ce92-2b8c-e063-6394a90a8b76	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Umedica Laboratories USA Inc.	b49f6c18-e155-4728-a79a-9354e8c3c8f4	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	0f8488f3-851d-4111-af23-60f420aad0d6	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	bca751bb-5161-5a95-e053-2a95a90aa2dd	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	2556c804-7a5e-4dbd-aeef-a3ba3a247c39	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	f67ef513-1b2c-42fe-bf33-4c7e9db191a3	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Calvin Scott & Co., Inc.	7da75d2b-905c-4fdf-bc53-1358c6477755	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58407-510	ZolpiMIST	Zolpidem Tartrate	Magna Pharmaceuticals, Inc.	NDA	Current
58407-510	ZolpiMIST	Zolpidem Tartrate	Magna Pharmaceuticals, Inc.	NDA	Current
69654-510	ZOLPIMIST	zolpidem tartrate	Aytu BioScience, Inc.	NDA	Current
69654-510	ZOLPIMIST	zolpidem tartrate	Aytu BioScience, Inc.	NDA	Current
69654-510	ZOLPIMIST	zolpidem tartrate	Aytu BioPharma, Inc.	NDA	Current
69654-510	ZOLPIMIST	zolpidem tartrate	Aytu BioPharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59766	SUPPL	2019-08-20
59765	SUPPL	2019-08-20
59748	SUPPL	2019-08-20
57603	SUPPL	2019-02-14
57471	SUPPL	2019-02-07
23702	ORIG	2013-04-29
29389	SUPPL	2011-10-03
29388	SUPPL	2010-10-19
42443	ORIG	2009-07-22
24257	ORIG	2009-07-22
17068	ORIG	2009-01-06
29387	ORIG	2008-12-29