FDA.reportPublic FDA data

Application 088388

Type
ANDA
Sponsor
DEPROCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SCANDONEST LLEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.05MG/ML;2%NoYes

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

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
A088388-001SCANDONEST LLEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE0.05MG/ML;2%INJECTABLE / INJECTION1984-10-10

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A088388-001SCANDONEST L0.05MG/ML;2%INJECTABLE / INJECTIONRS1984-10-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088388-001SCANDONEST L0.05MG/ML;2%INJECTABLE / INJECTIONRS1984-10-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088388-001SCANDONEST L0.05MG/ML;2%INJECTABLE / INJECTIONRS1984-10-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088388-001SCANDONEST L0.05MG/ML;2%INJECTABLE / INJECTION1984-10-10a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

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
0362-0931Carbocaine with Neo-CobefrinMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
0362-0931Carbocaine with Neo-CobefrinMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
0362-0931Carbocaine with Neo-CobefrinMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
0362-1097Scandonest 2% LMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
0362-1097Scandonest 2% LMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
0362-1097Scandonest 2% LMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
0362-1097Scandonest 2% LMepivacaine Hydrochloride and LevonordefrinSeptodont, Inc.ANDACurrent
31382-931Carbocaine with Neo-CobefrinMepivacaine hydrochloride and LevonordefrinCaresteam Health, Inc.ANDACurrent
51004-1097Scandonest LMepivacaine Hydrochloride and LevonordefrinNovocol Pharmaceutical of Canada, IncANDACurrent
66467-9790Mepivacaine Hydrochloride and LevonordefrinMepivacaine Hydrochloride and LevonordefrinDarby Dental Supply, LLCANDACurrent