FDA.reportPublic FDA data

Application 077239

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZALEPLONZALEPLONCAPSULE;ORAL5MGNoNo
002ZALEPLONZALEPLONCAPSULE;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077239-001ZALEPLONZALEPLON5MGCAPSULE / ORAL2008-06-06
A077239-002ZALEPLONZALEPLON10MGCAPSULE / ORAL2008-06-06

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077239-001ZALEPLON5MGCAPSULE / ORALAB2008-06-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077239-002ZALEPLON10MGCAPSULE / ORALAB2008-06-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077239-001ZALEPLON5MGCAPSULE / ORAL2008-06-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A077239-002ZALEPLON10MGCAPSULE / ORAL2008-06-06782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077239-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077239-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077239-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077239-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077239-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077239-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077239-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077239-002AB1ea99ee380514…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZaleplonZALEPLONPD-Rx Pharmaceuticals, Inc.a1277ef5-6072-43ff-a6ce-0a7cea58b7cb2025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zaleplon
generic name: ZALEPLON
zaleplonZALEPLONPD-Rx Pharmaceuticals, Inc.2cc7adee-2c4c-4fed-9914-545e70dba7732025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zaleplon
generic name: ZALEPLON
ZALEPLONZALEPLONPD-Rx Pharmaceuticals, Inc.9c83b71e-8344-4c77-b7f6-a9c862f9e7dd2025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZALEPLON
generic name: ZALEPLON
zaleplonZALEPLONPreferred Pharmaceuticals Inc.b0476859-07af-47f1-aec7-61aea0d99d242025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zaleplon
generic name: ZALEPLON
ZaleplonZALEPLONPreferred Pharmaceuticals Inc.d58138d1-3378-482c-a401-958dabe1be7d2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zaleplon
generic name: ZALEPLON
ZaleplonZALEPLONBryant Ranch Prepack517953c8-22ad-41af-a869-b7e4e5b291ae2024-08-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zaleplon
generic name: ZALEPLON
ZALEPLONZALEPLONBryant Ranch Prepackbec67c5d-9f8f-4490-a0b4-9b7905b565f12024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZALEPLON
generic name: ZALEPLON
ZALEPLONZALEPLONRising Pharma Holdings, Inc.cff46def-c452-49bb-abea-480de8f432bd2024-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZALEPLON
generic name: ZALEPLON
ZALEPLONZALEPLONAurobindo Pharma Limitede092f3ca-bf44-4568-a72c-3fb2cf5b192b2024-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ZALEPLON
generic name: ZALEPLON
ZaleplonZALEPLONBionpharma Inc.53103d2f-4453-49a8-9e36-888d919879f62024-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zaleplon
generic name: ZALEPLON
zaleplonZALEPLONA-S Medication Solutions8276a418-6a4c-4b81-8170-2d3838576c6d2024-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zaleplon
generic name: ZALEPLON
zaleplonZALEPLONBryant Ranch Prepackd8c88122-ce04-4caf-bd4d-0a4368ea89ad2023-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zaleplon
generic name: ZALEPLON
zaleplonZALEPLONBryant Ranch Prepackb8032b14-5068-19d5-e063-839ed25d72002023-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zaleplon
generic name: ZALEPLON
zaleplonZALEPLONUnichem Pharmaceuticals (USA), Inc.57a1a11d-7767-4caf-b98a-75d7561d91652021-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: zaleplon
generic name: ZALEPLON
ZaleplonZALEPLONHikma Pharmaceuticals USA Inc.cadd9d75-2139-4fab-94ce-2992e6a557802019-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zaleplon
generic name: ZALEPLON

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5268ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5268ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5269ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5269ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3420ZaleplonZaleplonA-S Medication SolutionsANDACurrent
50436-1006ZaleplonZaleplonUnit Dose ServicesANDACurrent
55700-190ZaleplonZaleplonLake Erie Medical DBA Quality Care Products LLCANDACurrent
66336-056ZaleplonZaleplonDispensing Solutions, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18458ORIG2008-07-14
23864ORIG2008-07-01
31209ORIG2008-06-10