Home Applications 078395 Application 078395
Type ANDA
Sponsor RUBICON Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078395-001 DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2008-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078395-001 AT
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 · 44 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 2022-10-28 04:53 UTC 2022-10 A078395-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC 2008-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078395-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC 2008-10-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078395-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC 2008-10-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078395-001 DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE SOLUTION/DROPS / OPHTHALMIC AT 2008-10-28 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 31364 ORIG 2008-11-03