Home Applications 078772 Application 078772
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.01MG/ML;2% No No 002 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.02MG/ML;2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078772-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;2% INJECTABLE / INJECTION 2008-05-12 A078772-002 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.02MG/ML;2% INJECTABLE / INJECTION 2008-05-12
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 A078772-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.01MG/ML;2% INJECTABLE / INJECTION 2008-05-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A078772-002 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.02MG/ML;2% INJECTABLE / INJECTION 2008-05-12 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 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Hospira, Inc. 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 2026-06-24 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Henry Schein, Inc. 27194739-3382-46b0-94cd-096531345325 2026-06-19 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Cardinal Health 107, LLC 77fd6ee4-108f-4525-8df5-7db9236042ee 2026-05-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Henry Schein, Inc. 5569d607-f1cb-4f1d-8a00-d50433ec05d3 2026-05-07 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Sportpharm LLC 2c58deba-dbb2-4e73-a173-36053536f03e 2026-04-22 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Henry Schein, Inc. c3490a23-14c4-43f7-b066-96a4c4298fde 2026-04-14 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE ProPharma Distribution 43048b6b-3c83-eef4-e063-6294a90a34cb 2025-12-18 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Henry Schein, Inc. e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b 2025-06-03 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Henry Schein, Inc. 5692e28d-559c-4b6a-8421-fa85d7155818 2025-02-21 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride and Epinephrine