FDA.reportPublic FDA data

Application 220493

Type
ANDA
Sponsor
ANTHEA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%NoNo
002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo
003BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.75%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220493-001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22
A220493-002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22
A220493-003BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A220493-001AP
A220493-002AP
A220493-003AP

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
2026-10-15 13:18:302026-09A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22c2088c7a36db…
2026-10-15 13:18:302026-09A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22c2088c7a36db…
2026-10-15 13:18:302026-09A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22c2088c7a36db…
2026-09-14 22:38:342026-08A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2026-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2026-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-003BUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2026-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A220493-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A220493-002AP1c2088c7a36db…
2026-10-15 13:18:302026-09A220493-003AP1c2088c7a36db…
2026-09-14 22:38:342026-08A220493-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A220493-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A220493-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A220493-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220493-003AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220493-003AP1a50c72e98297…

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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEFosun Pharma USA Inc.3a996abe-0bb9-4590-e063-6394a90a0b602025-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEEugia US LLCffecf450-1f01-4721-8e10-2513858526122025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHuons Co., Ltd.2dc693df-3218-4a90-b3f7-21e80966a8512024-11-20Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCb6bfc04a-1868-4630-9ca1-8c027af97ce32024-11-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst950d82b6-76a1-0c08-e053-2a95a90a3a922024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPIVACAINE HYDROCHLORIDE
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine hydrochlorideBUPIVACAINE HYDROCHLORIDESomerset Therapeutics, LLCbcaab86f-20f0-4482-8d73-e29b36dced582024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEA-S Medication Solutions1091d4d8-5dad-46e1-8f26-7bc0c5dd833f2024-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.8815c8c6-eed8-4afe-a5c1-44d2194025a32024-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.4595c642-1869-436c-9550-8f9f255efd272024-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.f37a19ad-5e69-44a8-947b-847df2106fb32023-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.8759cac8-d977-4c2a-814c-5b59f2f0c9102023-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Marvona SUIKBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.f03f28d9-e42e-404d-9c9c-7707aedb478c2023-07-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochlorideBUPIVACAINE HYDROCHLORIDEMeitheal Pharmaceuticals Incfe340f98-a0f3-446e-b281-47fd91c1e5372023-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupivacaine hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLC3335dabe-66d5-440b-a59a-b62993030e0f2023-06-09Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCf29c905e-9a55-446f-a89d-860ad9ade7ad2023-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC694926ac-aff0-aa1f-e053-2991aa0a95882023-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCe700eb7b-8b14-49c9-96b2-331f18776e452023-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6a9bf-f7cb-035a-e053-2a95a90a6a3d2023-05-03Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd1642239-4230-b679-e053-2a95a90a3b7c2023-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.