Home Applications 200678 Application 200678
Type NDA
Sponsor ASTRAZENECA AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG;EQ 5MG BASE Yes No 002 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 5MG BASE Yes Yes 003 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 2.5MG BASE Yes No
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 N200678-001 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2010-11-05 N200678-002 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2010-11-05 N200678-003 KOMBIGLYZE XR METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2010-11-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N200678-001 M-14 2027-10-11 N200678-002 M-14 2027-10-11 N200678-003 M-14 2027-10-11
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 N200678-001 KOMBIGLYZE XR 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2010-11-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N200678-002 KOMBIGLYZE XR 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2010-11-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N200678-003 KOMBIGLYZE XR 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2010-11-05 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N200678-001 M-14 2027-10-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N200678-002 M-14 2027-10-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N200678-003 M-14 2027-10-11 a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6125 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6135 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current 0310-6145 KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE AstraZeneca Pharmaceuticals LP NDA Current