Home Applications 217388 Application 217388
Type NDA
Sponsor ASTRAZENECA AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WAINUA (AUTOINJECTOR) EPLONTERSEN SODIUM SOLUTION;SUBCUTANEOUS EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) Yes Yes 002 WAINUA EPLONTERSEN SODIUM SOLUTION;SUBCUTANEOUS EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N217388-001 WAINUA (AUTOINJECTOR) EPLONTERSEN SODIUM EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 N217388-002 WAINUA EPLONTERSEN SODIUM EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 N217388-002 9127276 2034-05-01 Drug substance 2026-06-12 N217388-002 9181549 2034-05-01 Drug substance 2026-06-12 N217388-002 10683499 2034-08-25 U-2378 Drug substance, Drug product 2026-06-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217388-001 NCE 2028-12-21 N217388-001 ODE-461 2030-12-21
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 2026-08-18 06:07:40 2026-07 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217388-001 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217388-002 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 78 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 9127276 2034-05-01 Drug substance 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 9181549 2034-05-01 Drug substance 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 10683499 2034-08-25 U-2378 Drug substance, Drug product 2026-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 d8e5a09893c0…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WAINUA EPLONTERSEN AstraZeneca Pharmaceuticals LP d7dcb847-71dd-4fff-82d0-d43a465fc096 2026-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 217388 application number: NDA217388
Documents# Document, Submission type, Date table Document Submission type Date 85712 SUPPL 2026-04-20 85697 SUPPL 2026-04-16 84465 SUPPL 2025-12-19 82104 SUPPL 2025-05-01 82030 SUPPL 2025-04-28 79745 SUPPL 2024-09-26 79742 SUPPL 2024-09-26 77197 ORIG 2024-01-09 77109 ORIG 2023-12-22 77100 ORIG 2023-12-21