Application 208829

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL7.5MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoNo
005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208829-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24
A208829-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24
A208829-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24
A208829-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24
A208829-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-09-14 22:38:342026-08A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-2484e616aacf4f…
2026-08-18 06:07:402026-07A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORAL2017-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208829-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORAL2017-05-2403ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208829-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208829-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208829-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208829-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208829-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208829-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208829-005AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208829-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208829-005AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208829-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208829-005AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208829-005AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208829-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A208829-005AB15aa47cf7b7d7…

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 7 of 9 · 164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack267d8897-90dd-4f8a-bbd8-8aa4e47c29052024-07-09Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackdb32a7ec-5b50-4305-8952-df22e7e871e22024-07-09Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAPNAR PHARMA LP3c115eea-9dbc-4e2c-9d79-42e3388fde5a2024-06-17Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAmerican Health Packaginge80d83a6-7c2a-478e-bdf1-c481824fc3012024-06-07Warnings, Adverse reactionsName fallback
brand name: Buspirone hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19afb386-72a5-c97e-e063-6294a90adaea2024-05-30Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionscff1c7b2-4edb-4b5a-9626-2f7b8671b0152024-05-22Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONEBoswell Pharmacy Services d/b/a BPS Wholesale18e90d65-4a3a-864e-e063-6294a90ae99d2024-05-15Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions2a25a718-306f-403e-9928-cae30bc52f122024-05-06Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka2867dde-e5dd-4cc8-84d0-59240626868a2024-04-05Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeab53fff-c052-4466-a673-3d68aab98c272024-04-05Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2a8b3b75-5d93-4a9e-a583-49ccddd656502024-04-03Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka738c103-134a-401f-b14c-49a599130b8d2024-04-03Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack5fa0720f-e236-4b8b-a0c0-6f48037c76b32024-04-03Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEProficient Rx LP75b1ae3f-e926-4555-a0e9-50323fc66cb22024-02-01Warnings, Adverse reactionsName fallback
brand name: BUSPIRONE HYDROCHLORIDE
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1886b672-4b88-4b49-ae6a-d2ba2f452e442024-01-01Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionsbce96786-4d9a-460e-8d92-9908ea2af07a2023-12-27Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.a6bdf140-075e-445e-a62d-633a4b97f3a82023-12-22Warnings, Adverse reactionsName fallback
brand name: Buspirone Hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackb07c0a91-892c-47f5-819e-a128e0ef1ed72023-12-15Warnings, Adverse reactionsName fallback
brand name: Buspirone hydrochloride
generic name: BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack55e32128-711d-4e95-b58b-e86e0afa49832023-12-05Warnings, Adverse reactionsName fallback
brand name: BUSPIRONE HYDROCHLORIDE
generic name: BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackd47cde56-e1ab-41fe-832e-d3f33b884a5e2023-11-28Warnings, Adverse reactionsName fallback
brand name: BUSPIRONE HYDROCHLORIDE
generic name: BUSPIRONE HYDROCHLORIDE

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4657busPIRone HClbuspirone hydrochlorideA-S Medication SolutionsANDACurrent
50090-4657busPIRone HClbuspirone hydrochlorideA-S Medication SolutionsANDACurrent
50090-4657busPIRone HClbuspirone hydrochlorideA-S Medication SolutionsANDACurrent
55700-803busPIRone HClbuspirone hydrochlorideQuality Care Products, LLCANDACurrent
69238-1115busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1115busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1115busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1115busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1115busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1116busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1116busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1116busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1116busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1116busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1117busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1117busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1117busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1117busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1117busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1118busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1118busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1118busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1118busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1118busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1119busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1119busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1119busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1119busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1119busPIRone HClbuspirone hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
71335-1390busPIRone HClbuspirone hydrochlorideBryant Ranch PrepackANDACurrent
71335-1390busPIRone HClbuspirone hydrochlorideBryant Ranch PrepackANDACurrent