Home Applications 016758 Application 016758
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAVANE THIOTHIXENE HYDROCHLORIDE CONCENTRATE;ORAL EQ 5MG BASE/ML 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 N016758-001 NAVANE THIOTHIXENE HYDROCHLORIDE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CONCENTRATE / ORAL RLD, Approved before 1982
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 N016758-001 NAVANE EQ 5MG BASE/ML CONCENTRATE / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N016758-001 NAVANE EQ 5MG BASE/ML CONCENTRATE / ORAL RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016758-001 NAVANE EQ 5MG BASE/ML CONCENTRATE / ORAL RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016758-001 NAVANE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CONCENTRATE / ORAL RLD, Approved before 1982 a50c72e98297…
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 10920 SUPPL 2009-07-27 492 SUPPL 2009-07-24 491 SUPPL 2008-04-17 10919 SUPPL 2008-04-16 10918 SUPPL 2004-06-09 13028 SUPPL 2001-07-31 13027 SUPPL 2001-07-31