Home Applications 022363 Application 022363
Type NDA
Sponsor KOWA CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIVALO PITAVASTATIN CALCIUM TABLET;ORAL EQ 1MG BASE Yes No 002 LIVALO PITAVASTATIN CALCIUM TABLET;ORAL EQ 2MG BASE Yes No 003 LIVALO PITAVASTATIN CALCIUM TABLET;ORAL EQ 4MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022363-001 LIVALO PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 N022363-002 LIVALO PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 N022363-003 LIVALO PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66869-104 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-104 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-104 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-204 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-204 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-204 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-404 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-404 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current 66869-404 Livalo pitavastatin calcium Kowa Pharmaceuticals America, Inc. NDA Current