Application 202557

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
A202557-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30
A202557-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30
A202557-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30
A202557-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-30
A202557-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202557-001AB
A202557-002AB
A202557-003AB
A202557-004AB
A202557-005AB

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 22:38:342026-08A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-3084e616aacf4f…
2026-08-18 06:07:402026-07A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2014-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2014-12-3003ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202557-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202557-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202557-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A202557-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A202557-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A202557-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202557-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202557-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202557-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202557-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202557-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202557-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202557-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202557-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202557-005AB103ed91905a0d…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack66df7f74-5dea-46d6-9ef8-9bab37baf4072026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
ndc (product): 71335-0007
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7db10b76-4520-496e-b450-66a662cc95f62026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDIRECT RXbae98d45-e192-56e3-e053-2a95a90aadc32026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
ndc (product): 72189-175
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDirect_Rx8e9c0553-c994-f54a-e053-2a95a90a6fa32026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCf318ba7b-121f-2e4f-e053-2a95a90a60c52026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAccord Healthcare Inc.3da22999-f5fb-49fd-acde-c3006598e9852025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.540e9b7e-09ff-2cca-e054-00144ff8d46c2024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions4ae45cb1-8612-4006-b12c-2440160132ac2023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfac49d42-7bc0-435f-bce2-2548dcdd6de62018-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
ndc (product): 71610-208
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8b6e7ae6-5b83-4a5a-ab45-cf4be4287d782018-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202557
application number: ANDA202557
ndc (product): 71610-165

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 2 of 2 · 119 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1404Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1404Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1404Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1404Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1530Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3382Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3561Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-184Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-184Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-184Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-426Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-426Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-967Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-967Buspirone HydrochlorideBuspirone HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0007Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0007Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0007Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0007Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0562Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0562Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0562Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0562Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0985Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0985Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0985Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0991Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0991Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-0991Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71610-165Buspirone HydrochlorideBuspirone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-208Buspirone HydrochlorideBuspirone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-344Buspirone HydrochlorideBuspirone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-175BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-175BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEDIRECT RXANDACurrent