FDA.reportPublic FDA data

Application 088653

Type
ANDA
Sponsor
DENTSPLY PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLOCAINEMEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION3%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A088653-001POLOCAINEMEPIVACAINE HYDROCHLORIDE3%INJECTABLE / INJECTION1984-08-21

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 2 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088653-001POLOCAINE3%INJECTABLE / INJECTION1984-08-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088653-001POLOCAINE3%INJECTABLE / INJECTION1984-08-21a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scandonest 3% PlainMEPIVACAINE HYDROCHLORIDESeptodont, Inc.af6ff5f6-7221-421b-9b7c-8fcee4a477722025-05-29Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDEMEPIVACAINE HYDROCHLORIDESafco Dental Supply Co.c4d45717-86c9-45bf-ba8e-2c255814ab502024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
MepivacaineMEPIVACAINE HYDROCHLORIDENovocol Pharmaceutical of Canada, Inc.f58cb2c7-22a6-4341-8f9a-85c5628af7972024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
MepivacaineMEPIVACAINE HYDROCHLORIDEDarby Dental Supply, LLC5e81dae6-e55b-4d5e-9318-1d9395db052e2024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
Mepivacaine HydrochlorideMEPIVACAINE HYDROCHLORIDEHenry Schein Inc.a3c2cddc-827b-4644-9060-e2fd2188b4592024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
CarbocaineMEPIVACAINE HYDROCHLORIDESeptodont, Inc.1f2f9e40-e437-4124-97b7-df67dbafd1542024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
PolocaineMEPIVACAINE HYDROCHLORIDENovocol Pharmaceutical of Canada Inc.eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf2024-02-21Warnings, Adverse reactionsName fallback
brand name: Polocaine
generic name: MEPIVACAINE HYDROCHLORIDE
MepivacaineMEPIVACAINE HYDROCHLORIDEBenco Dentalc9a5a849-d010-4637-a66a-c26176401fbd2024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
MepivacaineMEPIVACAINE HYDROCHLORIDENDC, Inc.042010fb-7161-4336-b91f-5a25839ee6442024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
MepivacaineMEPIVACAINE HYDROCHLORIDEPatterson Dental Supply, Inc.e8a3df4b-e918-4813-af3e-3c95f2c542502024-02-21Warnings, Adverse reactionsName fallback
generic name: MEPIVACAINE HYDROCHLORIDE
PolocaineMEPIVACAINE HYDROCHLORIDEDentsply Pharmaceutical25074a6a-7f67-4ad8-86e0-2afe23ec5d042024-02-21Warnings, Adverse reactionsName fallback
brand name: Polocaine
generic name: MEPIVACAINE HYDROCHLORIDE
Polocaine-MPFMEPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCa27d0815-ae6b-4a21-a8f5-564c01e838142022-10-01Warnings, Adverse reactionsName fallback
brand name: Polocaine
generic name: MEPIVACAINE HYDROCHLORIDE