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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.a60303c2-5217-41db-855b-83fa2a749da22022-10-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupivacaine Hydrochloride
generic name: BUPIVACAINE HYDROCHLORIDE
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdcf3c0ad-9eb8-4ee7-96df-d0db7ff231752022-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.3eefbefe-78ae-4f2d-9be6-3f79eadcff862020-04-09Boxed 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.