Home Applications 201751 Application 201751
Type ANDA
Sponsor HANSAMED INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ULTACAN ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A201751-001 ULTACAN ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) INJECTABLE / INJECTION 2017-07-11
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 · 43 observed 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 2022-09-29 23:25 UTC 2022-09 A201751-001 ULTACAN 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201751-001 ULTACAN 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201751-001 ULTACAN 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52120-200 Ultacan articaine hydrochloride, epinephrine bitartrate HANSAmed, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 48968 ORIG 2017-07-13 48951 ORIG 2017-07-11