Home Applications 077826 Application 077826
Type ANDA
Sponsor TEVA PARENTERAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FENOLDOPAM MESYLATE FENOLDOPAM MESYLATE INJECTABLE;INJECTION EQ 10MG 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 A077826-001 FENOLDOPAM MESYLATE FENOLDOPAM MESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2007-03-07
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 A077826-001 FENOLDOPAM MESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2007-03-07 a50c72e98297…
Documents# Document, Submission type, Date table Document Submission type Date 63368 ORIG 2020-06-01