Application 206321

Type
NDA
Sponsor
NOVO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAXENDALIRAGLUTIDE RECOMBINANTSOLUTION;SUBCUTANEOUS18MG/3ML (6MG/ML)YesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206321-001SAXENDALIRAGLUTIDE18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP2RLD, RS2014-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N206321-001AP2

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206321-00181148332025-08-13Drug product2015-01-21
N206321-0018114833*PED2026-02-13Pediatric extension
N206321-00199686592037-01-09U-24382018-11-16
N206321-0019968659*PED2037-07-09Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP2RLD, RS2014-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSAP2RLD, RS2014-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-233f01610625f2…
2019-09-15 20:21 UTC2019-09N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206321-001SAXENDA18MG/3ML (6MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2014-12-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N206321-001AP21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206321-001AP2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206321-001AP21a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206321-00181148332025-08-13Drug product2015-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206321-0018114833*PED2026-02-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206321-00199686592037-01-09U-24382018-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206321-0019968659*PED2037-07-09Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206321-00181148332025-08-13Drug product2015-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206321-0018114833*PED2026-02-13Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206321-00199686592037-01-09U-24382018-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206321-0019968659*PED2037-07-09Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N206321-00181148332025-08-13Drug product2015-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206321-0018114833*PED2026-02-13Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206321-00199686592037-01-09U-24382018-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206321-0019968659*PED2037-07-09Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00181148332025-08-13Drug product2015-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001114464432025-10-20Drug product2022-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00186849692025-10-20Drug product2015-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001103576162026-01-20Drug product2019-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001103766522026-01-20Drug product2019-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001113116792026-01-20Drug product2022-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00196161802026-01-20Drug product2018-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00198617572026-01-20Drug product2018-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00191080022026-01-26Drug product2015-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0018114833*PED2026-02-13Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0018684969*PED2026-04-20Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001102201552026-07-17Drug product2019-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001110970632026-07-17Drug product2021-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00189203832026-07-17Drug product2015-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00197759532026-07-17Drug product2017-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0019616180*PED2026-07-20Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0019861757*PED2026-07-20Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0019108002*PED2026-07-26Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001RE463632026-08-03Drug product2017-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00110220155*PED2027-01-17Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0018920383*PED2027-01-17Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0019775953*PED2027-01-17Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-001RE46363*PED2027-02-03Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00196876112027-02-27Drug product2017-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0019687611*PED2027-08-27Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00194571542027-09-27Drug product2016-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-0019457154*PED2028-03-27Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206321-00191322392032-02-01Drug product2015-09-18fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206321-001NPP2023-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206321-001NPP2023-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206321-001NPP2023-12-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N206321-001NPP2023-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206321-001NPP2023-12-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206321-001NPP2023-12-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N206321-001NPP2023-12-045aa47cf7b7d7…
2023-12-20 04:57 UTC2023-12N206321-001NPP2023-12-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206321-001NPP2023-12-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206321-001NPP2023-12-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206321-001NPP2023-12-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206321-001NPP2023-12-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N206321-001NPP2023-12-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N206321-001NPP2023-12-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206321-001NPP2023-12-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206321-001NPP2023-12-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206321-001NPP2023-12-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206321-001NPP2023-12-04cb3db0bc1861…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SaxendaLIRAGLUTIDENovo Nordisk Pharmaceutical Industries, LP3946d389-0926-4f77-a708-0acb8153b1432026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 206321
application number: NDA206321
ndc (product): 0169-2800
SaxendaLIRAGLUTIDEA-S Medication Solutions7b11f6ac-4c27-4748-9e65-22d4cf3adfb42024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 206321
application number: NDA206321
ndc (product): 50090-4257

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
50090-4257SaxendaliraglutideA-S Medication SolutionsNDACurrent
50090-4257SaxendaliraglutideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85188SUPPL 2026-03-02
85176SUPPL 2026-02-27
83789SUPPL 2025-10-15
83788SUPPL 2025-10-15
83772SUPPL 2025-10-15
82359SUPPL 2025-05-30
82345SUPPL 2025-05-29
80122SUPPL 2024-11-05
80103SUPPL 2024-11-04
74045SUPPL 2023-04-24
74037SUPPL 2023-04-21
71345SUPPL2022-06-16
71344SUPPL2022-06-16
71336SUPPL2022-06-16
65553SUPPL2020-12-09
65552SUPPL2020-12-09
65551SUPPL2020-12-09
65527SUPPL2020-12-08
65526SUPPL2020-12-08
65525SUPPL2020-12-08
62344SUPPL2020-03-26
62342SUPPL2020-03-26
62341SUPPL2020-03-26
58926SUPPL2019-06-03
56665SUPPL2018-12-07
56080SUPPL2018-10-23
56050SUPPL2018-10-22
48614SUPPL2017-06-01
48208SUPPL2017-05-02
48207SUPPL2017-05-02
48126SUPPL2017-04-27
48125SUPPL2017-04-27
48124SUPPL2017-04-27
48123SUPPL2017-04-27
45520SUPPL2016-10-12
45412SUPPL2016-09-29
32797SUPPL2016-02-02
43516ORIG2015-10-01
19715SUPPL2015-04-01
32796SUPPL2015-03-31
44600ORIG2014-12-31
40537ORIG2014-12-31
10560ORIG2014-12-31