Home Applications 022350 Application 022350
Type NDA
Sponsor ASTRAZENECA AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Yes No 002 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022350-001 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 N022350-002 ONGLYZA SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022350-001 7951400 2028-11-30 Drug product 2011-06-29 N022350-002 7951400 2028-11-30 Drug product
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 N022350-001 ONGLYZA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N022350-002 ONGLYZA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-31 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022350-001 7951400 2028-11-30 Drug product 2011-06-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N022350-002 7951400 2028-11-30 Drug product a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-6100 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6100 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6100 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6100 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6100 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6100 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6105 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6105 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6105 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6105 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6105 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 0310-6105 ONGLYZA SAXAGLIPTIN AstraZeneca Pharmaceuticals LP NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health 107, LLC NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current 55154-6931 ONGLYZA SAXAGLIPTIN Cardinal Health NDA Current