Application 204582

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204582-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18
A204582-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18
A204582-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18
A204582-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204582-001AB
A204582-002AB
A204582-003AB
A204582-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204582-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2015-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2015-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2015-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2015-09-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204582-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204582-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204582-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204582-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204582-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204582-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204582-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204582-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204582-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204582-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204582-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204582-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204582-004AB1d06236e962d9…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fd05160d-24c6-4371-8b2c-c0f78c8b468e2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (product): 70518-2660
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.a9fc7091-b3ce-45fd-8d89-aeebdd81c3272026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (product): 70518-2031
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack225575f1-9635-4922-8286-d479d6480bf02026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (product): 71335-1605
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeee7fa99-a9a1-4299-8a3d-6c2dd90948c92026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (product): 71335-1608
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC5424f933-93e1-4480-acdf-bd8667ae50e92026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLC1d883a13-4877-c6c7-e063-6294a90a51372025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4ff72575-bd60-40ce-b3a8-fd92b79af6742025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (product): 23155-097
ndc (product): 23155-024
ndc (product): 23155-025
ndc (product): 23155-023
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMajor Pharmaceuticals8dc1ee33-e5aa-4462-8fb9-9bbdf54634882025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204582
application number: ANDA204582
ndc (product): 0904-7121
ndc (product): 0904-7122

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7121Buspirone HydrochlorideBuspirone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7122Buspirone HydrochlorideBuspirone HydrochlorideMajor PharmaceuticalsANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-023Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-024Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-025Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-097Buspirone HydrochlorideBuspirone HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
55700-861Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
67046-558Buspirone HydrochlorideBuspirone HydrochlorideContract Pharmacy Services-PAANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1940Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2031Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2300Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2300Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2300Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2591Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2660Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2724Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1605Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1605Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1605Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1608Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1608Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71610-267Buspirone HydrochlorideBuspirone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32569ORIG2015-09-24