FDA.reportPublic FDA data

Application 078302

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078302-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2007-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078302-001AB

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 22:54:322026-06A078302-001BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2007-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078302-001AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.476f4f55-c6c1-4f39-950e-59236f4995772026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
ndc (product): 72789-142
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1521109d-8386-472f-9483-f1fe9f7ed1522026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeb072818-3ca8-430b-91a1-e7fedd37990c2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions38677cd0-2ee6-4c8f-8553-36310b2813a12025-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack790b6159-c03b-4a3a-be6b-add35a3114a42025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEOxford Pharmaceuticals, LLC97fcebc1-6615-4b9d-b0f3-6434850f407c2025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
ndc (product): 69584-094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack696911d8-e97a-4c8e-9341-782b4c63bf032024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
ndc (product): 63629-2415
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack8bb7991e-ab09-4602-b49d-0a72a501685b2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078302
application number: ANDA078302
ndc (product): 63629-2414

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2414Buspirone Hydrochloridebuspirone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2414Buspirone Hydrochloridebuspirone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2415Buspirone Hydrochloridebuspirone hydrochlorideBryant Ranch PrepackANDACurrent
63629-2415Buspirone Hydrochloridebuspirone hydrochlorideBryant Ranch PrepackANDACurrent
69584-094Buspirone Hydrochloridebuspirone hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
69584-094Buspirone Hydrochloridebuspirone hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
69584-094Buspirone Hydrochloridebuspirone hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
69584-094Buspirone Hydrochloridebuspirone hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
72789-142Buspirone Hydrochloridebuspirone hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-142Buspirone Hydrochloridebuspirone hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-142Buspirone Hydrochloridebuspirone hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent