Home Applications 209091 Application 209091
Type NDA
Sponsor ASTRAZENECA AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL 10MG;EQ 5MG BASE Yes Yes 002 QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL 5MG;EQ 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209091-001 QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2017-02-27 N209091-002 QTERN DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-02
Orange Book patents# Current patent rows page 1 of 1 · 28 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209091-001 6515117 2025-10-04 U-493 Drug substance, Drug product 2017-03-22 N209091-001 6515117*PED 2026-04-04 Pediatric extension N209091-001 8501698 2027-06-20 U-1976 Drug product 2017-03-22 N209091-001 8501698 2027-06-20 U-1977 Drug product 2017-03-22 N209091-001 8501698 2027-06-20 U-493 Drug product 2017-03-22 N209091-001 8501698*PED 2027-12-20 Pediatric extension N209091-001 8221786 2028-03-21 Drug product 2017-03-22 N209091-001 8361972 2028-03-21 U-1976 2017-03-22 N209091-001 8361972 2028-03-21 U-1977 2017-03-22 N209091-001 8361972 2028-03-21 U-493 2017-03-22 N209091-001 8716251 2028-03-21 Drug product 2017-03-22 N209091-001 8221786*PED 2028-09-21 Pediatric extension N209091-001 8361972*PED 2028-09-21 Pediatric extension N209091-001 8716251*PED 2028-09-21 Pediatric extension N209091-001 7919598 2029-12-16 Drug substance 2017-03-22 N209091-001 7919598*PED 2030-06-16 Pediatric extension N209091-002 6515117 2025-10-04 U-493 Drug substance, Drug product 2019-05-24 N209091-002 6515117*PED 2026-04-04 Pediatric extension N209091-002 8501698 2027-06-20 U-493 Drug product 2019-05-24 N209091-002 8501698*PED 2027-12-20 Pediatric extension N209091-002 8221786 2028-03-21 Drug product 2019-05-24 N209091-002 8361972 2028-03-21 U-493 2019-05-24 N209091-002 8716251 2028-03-21 Drug product 2019-05-24 N209091-002 8221786*PED 2028-09-21 Pediatric extension N209091-002 8361972*PED 2028-09-21 Pediatric extension N209091-002 8716251*PED 2028-09-21 Pediatric extension N209091-002 7919598 2029-12-16 Drug substance 2019-05-24 N209091-002 7919598*PED 2030-06-16 Pediatric extension
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 N209091-001 QTERN 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2017-02-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 QTERN 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-02 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 N209091-001 6515117 2025-10-04 U-493 Drug substance, Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 6515117*PED 2026-04-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698 2027-06-20 U-1976 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698 2027-06-20 U-1977 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698 2027-06-20 U-493 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8501698*PED 2027-12-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8221786 2028-03-21 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972 2028-03-21 U-1977 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972 2028-03-21 U-1976 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972 2028-03-21 U-493 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8716251 2028-03-21 Drug product 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8221786*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8361972*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 8716251*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 7919598 2029-12-16 Drug substance 2017-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-001 7919598*PED 2030-06-16 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 6515117 2025-10-04 U-493 Drug substance, Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 6515117*PED 2026-04-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8501698 2027-06-20 U-493 Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8501698*PED 2027-12-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8221786 2028-03-21 Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8361972 2028-03-21 U-493 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8716251 2028-03-21 Drug product 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8221786*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8361972*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 8716251*PED 2028-09-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 7919598 2029-12-16 Drug substance 2019-05-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N209091-002 7919598*PED 2030-06-16 Pediatric extension a50c72e98297…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6770 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current 0310-6780 QTERN dapagliflozin and saxagliptin AstraZeneca Pharmaceuticals LP NDA Current