Home Applications 206321 Application 206321
Type NDA
Sponsor NOVO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAXENDA LIRAGLUTIDE RECOMBINANT SOLUTION;SUBCUTANEOUS 18MG/3ML (6MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N206321-001 SAXENDA LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206321-001 AP2
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206321-001 8114833 2025-08-13 Drug product 2015-01-21 N206321-001 8114833*PED 2026-02-13 Pediatric extension N206321-001 9968659 2037-01-09 U-2438 2018-11-16 N206321-001 9968659*PED 2037-07-09 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS AP2 RLD, RS 2014-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206321-001 SAXENDA 18MG/3ML (6MG/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2014-12-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206321-001 AP2 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 AP2 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N206321-001 AP2 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 36 · 1,420 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206321-001 8114833*PED 2026-02-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206321-001 9968659*PED 2037-07-09 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 8114833*PED 2026-02-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206321-001 9968659*PED 2037-07-09 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206321-001 8114833*PED 2026-02-13 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206321-001 9968659 2037-01-09 U-2438 2018-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206321-001 9968659*PED 2037-07-09 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8114833 2025-08-13 Drug product 2015-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 11446443 2025-10-20 Drug product 2022-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8684969 2025-10-20 Drug product 2015-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10357616 2026-01-20 Drug product 2019-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10376652 2026-01-20 Drug product 2019-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 11311679 2026-01-20 Drug product 2022-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9616180 2026-01-20 Drug product 2018-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9861757 2026-01-20 Drug product 2018-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9108002 2026-01-26 Drug product 2015-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8114833*PED 2026-02-13 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8684969*PED 2026-04-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10220155 2026-07-17 Drug product 2019-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 11097063 2026-07-17 Drug product 2021-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8920383 2026-07-17 Drug product 2015-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9775953 2026-07-17 Drug product 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9616180*PED 2026-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9861757*PED 2026-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9108002*PED 2026-07-26 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 RE46363 2026-08-03 Drug product 2017-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 10220155*PED 2027-01-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 8920383*PED 2027-01-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9775953*PED 2027-01-17 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 RE46363*PED 2027-02-03 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9687611 2027-02-27 Drug product 2017-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9687611*PED 2027-08-27 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9457154 2027-09-27 Drug product 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9457154*PED 2028-03-27 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206321-001 9132239 2032-02-01 Drug product 2015-09-18 fd3edfee7708…
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0169-2800 Saxenda liraglutide Novo Nordisk NDA Current 0169-2800 Saxenda liraglutide Novo Nordisk NDA Current 0169-2800 Saxenda liraglutide Novo Nordisk NDA Current 0169-2800 Saxenda liraglutide Novo Nordisk NDA Current 0169-2800 Saxenda liraglutide Novo Nordisk NDA Current 0169-2800 Saxenda liraglutide Novo Nordisk NDA Current 50090-4257 Saxenda liraglutide A-S Medication Solutions NDA Current 50090-4257 Saxenda liraglutide A-S Medication Solutions NDA Current