Home Applications 214231 Application 214231
Type NDA
Sponsor ZEALAND PHARMA AS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEGALOGUE DASIGLUCAGON INJECTABLE;INJECTION 0.6MG/0.6ML Yes No 002 ZEGALOGUE (AUTOINJECTOR) DASIGLUCAGON HYDROCHLORIDE SOLUTION;SUBCUTANEOUS EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N214231-001 ZEGALOGUE DASIGLUCAGON HYDROCHLORIDE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2021-03-22 N214231-002 ZEGALOGUE (AUTOINJECTOR) DASIGLUCAGON HYDROCHLORIDE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2021-03-22
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 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 N214231-001 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 N214231-002 10442847 2035-03-22 Drug substance, Drug product 2021-04-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 2 of 2 · 74 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 2022-03-09 01:35 UTC 2022-03 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-03-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214231-001 ZEGALOGUE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2021-03-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214231-002 ZEGALOGUE (AUTOINJECTOR) EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2021-03-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 114 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214231-001 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214231-002 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214231-001 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214231-002 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214231-001 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214231-002 10442847 2035-03-22 Drug substance, Drug product 2021-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214231-001 11795204 2034-01-06 U-3752 2023-11-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214231-001 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214231-002 11795204 2034-01-06 U-3752 2023-11-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214231-002 10442847 2035-02-03 Drug substance, Drug product 2021-04-21 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 observed states.
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 80644-0012 Zegalogue dasiglucagon Zealand Pharma A/S NDA Current 80644-0012 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0012 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0012 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0012 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0013 Zegalogue dasiglucagon Zealand Pharma A/S NDA Current 80644-0013 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0013 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0013 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current 80644-0013 Zegalogue dasiglucagon Zealand Pharma US, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67117 ORIG 2021-04-19 66840 ORIG 2021-03-23 66833 ORIG 2021-03-22