Home Applications 075735 Application 075735
Type ANDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE;EQ 50MG 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 A075735-001 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET / ORAL AB 2001-07-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075735-001 AB
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 A075735-001 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET / ORAL AB 2001-07-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075735-001 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET / ORAL AB 2001-07-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075735-001 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET / ORAL AB 2001-07-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075735-001 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE TABLET / ORAL AB 2001-07-11 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43386-680 PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE pentazocine hydrochloride and naloxone hydrochloride Lupin Pharmaceuticals,Inc. ANDA Current 43386-680 PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE pentazocine hydrochloride and naloxone hydrochloride Lupin Pharmaceuticals,Inc. ANDA Current 43386-680 PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE pentazocine hydrochloride and naloxone hydrochloride Lupin Pharmaceuticals,Inc. ANDA Current 61919-556 PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIRECT RX ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76068 ORIG 2023-11-02