Application 022196

Type
NDA
Sponsor
AYTU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIMISTZOLPIDEM TARTRATESPRAY, METERED;ORAL5MG/SPRAYYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022196-001ZOLPIMISTZOLPIDEM TARTRATE5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022196-00182362852032-08-07U-70Drug 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-1984e616aacf4f…
2026-08-18 06:07:402026-07N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-193f01610625f2…
2019-09-15 20:21 UTC2019-09N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD2008-12-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022196-001ZOLPIMIST5MG/SPRAYSPRAY, METERED / ORALRLD, RS2008-12-19f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022196-00182362852032-08-07U-70Drug substance, Drug product84e616aacf4f…
2026-08-18 06:07:402026-07N022196-00182362852032-08-07U-70Drug substance, Drug productcaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022196-00182362852032-08-07U-70Drug substance, Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022196-00182362852032-08-07U-70Drug substance, Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022196-00182362852032-08-07U-70Drug substance, Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022196-00182362852032-08-07U-70Drug substance, Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022196-00182362852032-08-07U-70Drug substance, Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022196-00182362852032-08-07U-70Drug substance, Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022196-00182362852032-08-07U-70Drug substance, Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022196-00182362852032-08-07U-70Drug substance, Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022196-00182362852032-08-07U-70Drug substance, Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022196-00182362852032-08-07U-70Drug substance, Drug productd06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022196-00182362852032-08-07U-70Drug substance, Drug product79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022196-00182362852032-08-07U-70Drug substance, Drug product301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022196-00182362852032-08-07U-70Drug substance, Drug product1e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022196-00182362852032-08-07U-70Drug substance, Drug product8072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022196-00182362852032-08-07U-70Drug substance, Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022196-00182362852032-08-07U-70Drug substance, Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022196-00182362852032-08-07U-70Drug substance, Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022196-00182362852032-08-07U-70Drug substance, Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022196-00182362852032-08-07U-70Drug substance, Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022196-00182362852032-08-07U-70Drug substance, Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022196-00182362852032-08-07U-70Drug substance, Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N022196-00182362852032-08-07U-70Drug substance, Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022196-00182362852032-08-07U-70Drug substance, Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022196-00182362852032-08-07U-70Drug substance, Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022196-00182362852032-08-07U-70Drug substance, Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N022196-00182362852032-08-07U-70Drug substance, Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N022196-00182362852032-08-07U-70Drug substance, Drug productea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022196-00182362852032-08-07U-70Drug substance, Drug product6a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022196-00182362852032-08-07U-70Drug substance, Drug product1c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022196-00182362852032-08-07U-70Drug substance, Drug productea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022196-00182362852032-08-07U-70Drug substance, Drug producta72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022196-00182362852032-08-07U-70Drug substance, Drug product9b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022196-00182362852032-08-07U-70Drug substance, Drug producta67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022196-00182362852032-08-07U-70Drug substance, Drug product3f0d92c62455…
2023-05-13 08:27 UTC2023-05N022196-00182362852032-08-07U-70Drug substance, Drug product053a50430f4f…
2023-01-26 05:58 UTC2023-01N022196-00182362852032-08-07U-70Drug substance, Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022196-00182362852032-08-07U-70Drug substance, Drug product3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022196-00182362852032-08-07U-70Drug substance, Drug productf41ea6bd6efb…

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 3 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC349053e4-9885-ec0b-e063-6294a90ad79a2025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e15d6e3-8d06-0936-e063-6394a90ab8db2025-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC3310d63e-d79a-175d-e063-6394a90a42702025-04-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
AmbienZOLPIDEM TARTRATESanofi-Aventis U.S. LLCc36cadf4-65a4-4466-b409-c82020b424522025-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.30c057fb-2e1b-4b9c-8c8a-79c322151e612025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEPreferred Pharmaceuticals Inc.d579c6ca-c820-49ff-92fb-2e6aaad3b0522025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.e5e2d31b-ce26-78b0-e053-2a95a90ac4912025-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
AmbienZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.747949c5-2c91-4909-8a07-71b6826f8e972025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Ambien CRZOLPIDEM TARTRATECosette Pharmaceuticals, Inc.2d934da3-bd77-4470-e063-6294a90a64f52025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.38c838a4-9943-445a-8e80-e823d56eeaa52025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.fda413e7-b1ae-312a-e053-6394a90ab2c62025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXc3f23bc3-595b-28e5-e053-2a95a90a9c2c2025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc.2b9f696a-b637-4dea-e063-6394a90aeb2e2025-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87ae17-a3c5-a3a5-e053-2a95a90aa4b02024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87b722-cdb7-0b17-e053-2a95a90a315b2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87df4e-2c97-e23e-e053-2a95a90ab3542024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCb2db3979-daa6-6e83-e053-2a95a90a3a2f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc8adec28-9dcd-4a7e-e053-2a95a90a991e2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc859c752-8a85-2017-e053-2a95a90a771f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZOLPIDEM TARTRATE
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58407-510ZolpiMISTZolpidem TartrateMagna Pharmaceuticals, Inc.NDACurrent
58407-510ZolpiMISTZolpidem TartrateMagna Pharmaceuticals, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioScience, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioScience, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioPharma, Inc.NDACurrent
69654-510ZOLPIMISTzolpidem tartrateAytu BioPharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59766SUPPL2019-08-20
59765SUPPL2019-08-20
59748SUPPL2019-08-20
57603SUPPL2019-02-14
57471SUPPL2019-02-07
23702ORIG2013-04-29
29389SUPPL2011-10-03
29388SUPPL2010-10-19
42443ORIG2009-07-22
24257ORIG2009-07-22
17068ORIG2009-01-06
29387ORIG2008-12-29