FDA.reportPublic FDA data

Application 208972

Type
ANDA
Sponsor
EPIC PHARMA LLC

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
006BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
007BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL12.5MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208972-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-04-16
A208972-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2019-04-16
A208972-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-04-16
A208972-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-04-16
A208972-005BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-04-16
A208972-006BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE2.5MGTABLET / ORAL2026-05-13
A208972-007BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE12.5MGTABLET / ORAL2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208972-001AB
A208972-002AB
A208972-003AB
A208972-004AB
A208972-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208972-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-002BUSPIRONE HYDROCHLORIDE7.5MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-003BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-004BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-005BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-04-16a50c72e98297…
2026-08-01 22:54:322026-06A208972-006BUSPIRONE HYDROCHLORIDE2.5MGTABLET / ORAL2026-05-13a50c72e98297…
2026-08-01 22:54:322026-06A208972-007BUSPIRONE HYDROCHLORIDE12.5MGTABLET / ORAL2026-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208972-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A208972-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEIPG Pharmaceuticals, Inc2c516eec-65d9-4481-8823-ae6b6da840622026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208972
application number: ANDA208972
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27db85e9-68ef-4d43-a319-4e2ec8dbae052020-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208972
application number: ANDA208972
ndc (product): 71610-404
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEEpic Pharma, LLC02628a0c-bfdb-4a58-8e48-bcd8ca12d53b2019-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208972
application number: ANDA208972
ndc (product): 42806-082
ndc (product): 42806-085
ndc (product): 42806-086
ndc (product): 42806-083
ndc (product): 42806-084

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-082Buspirone HydrochlorideBuspirone HydrochlorideEpic Pharma, LLCANDACurrent
42806-083Buspirone HydrochlorideBuspirone HydrochlorideEpic Pharma, LLCANDACurrent
42806-084Buspirone HydrochlorideBuspirone HydrochlorideEpic Pharma, LLCANDACurrent
42806-085Buspirone HydrochlorideBuspirone HydrochlorideEpic Pharma, LLCANDACurrent
42806-086Buspirone HydrochlorideBuspirone HydrochlorideEpic Pharma, LLCANDACurrent
55700-881Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
70518-2830Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2830Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3607Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
71610-404Buspirone HydrochlorideBuspirone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent