Home Applications 079138 Application 079138
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) 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 A079138-001 ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2010-06-18
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 A079138-001 ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2010-06-18 a50c72e98297…
Documents# Document, Submission type, Date table Document Submission type Date 9225 ORIG 2010-06-24