Home Applications 070554 Application 070554
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.75% No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070554-001 SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 1986-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070554-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A070554-001 SENSORCAINE 0.75% INJECTABLE / INJECTION AP 1986-05-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A070554-001 AP 1 a50c72e98297…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SENSORCAINE BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Fresenius Kabi USA, LLC bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb 2023-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070554 application number: ANDA070554 ndc (product): 63323-472
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-472 SENSORCAINE BUPIVACAINE HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-472 SENSORCAINE BUPIVACAINE HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current