Home Applications 202402 Application 202402
Type ANDA
Sponsor XGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN LYSINE IBUPROFEN LYSINE INJECTABLE;INTRAVENOUS EQ 20MG BASE/2ML (EQ 10MG 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 A202402-001 IBUPROFEN LYSINE IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202402-001 AP
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 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 39822-1030 Ibuprofen Lysine Ibuprofen Lysine X-GEN Pharmaceuticals, Inc. ANDA Current 39822-1030 Ibuprofen Lysine Ibuprofen Lysine X-GEN Pharmaceuticals, Inc. ANDA Current 39822-1030 Ibuprofen Lysine Ibuprofen Lysine XGen Pharmaceuticals DJB, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 19343 ORIG 2016-04-11 10043 ORIG 2016-04-01