Home Applications 213976 Application 213976
Type NDA
Sponsor TAKEDA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EOHILIA BUDESONIDE SUSPENSION;ORAL 2MG/10ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N213976-001 EOHILIA BUDESONIDE 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213976-001 11197822 2026-11-09 Drug product 2024-03-04 N213976-001 11413296 2026-11-09 Drug product 2024-03-04 N213976-001 8497258 2026-11-09 U-3820 2024-03-04 N213976-001 8679545 2026-11-09 Drug product 2024-03-04 N213976-001 8975243 2026-11-09 U-3820 2024-03-04 N213976-001 9119863 2026-11-09 U-3820 2024-03-04 N213976-001 11357859 2028-11-12 U-3820 2024-03-04 N213976-001 10293052 2028-11-22 Drug product 2024-03-04 N213976-001 9050368 2029-08-01 Drug product 2024-03-04 N213976-001 8324192 2029-08-03 U-3820 2024-03-04 N213976-001 11260064 2039-01-10 Drug product 2024-03-04 N213976-001 11564934 2039-01-10 U-3820 2024-03-04
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213976-001 NP 2027-02-09 N213976-001 ODE-466 2031-02-09
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 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213976-001 EOHILIA 2MG/10ML SUSPENSION / ORAL RLD, RS 2024-02-09 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 204 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 N213976-001 11197822 2026-11-09 Drug product 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 11413296 2026-11-09 Drug product 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 8497258 2026-11-09 U-3820 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 8679545 2026-11-09 Drug product 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 8975243 2026-11-09 U-3820 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 9119863 2026-11-09 U-3820 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 11357859 2028-11-12 U-3820 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 10293052 2028-11-22 Drug product 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 9050368 2029-08-01 Drug product 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 8324192 2029-08-03 U-3820 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 11260064 2039-01-10 Drug product 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213976-001 11564934 2039-01-10 U-3820 2024-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213976-001 11197822 2026-11-09 Drug product 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 11413296 2026-11-09 Drug product 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 8497258 2026-11-09 U-3820 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 8679545 2026-11-09 Drug product 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 8975243 2026-11-09 U-3820 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 9119863 2026-11-09 U-3820 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 11357859 2028-11-12 U-3820 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 10293052 2028-11-22 Drug product 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 9050368 2029-08-01 Drug product 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 8324192 2029-08-03 U-3820 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 11260064 2039-01-10 Drug product 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213976-001 11564934 2039-01-10 U-3820 2024-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 11197822 2026-11-09 Drug product 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 11413296 2026-11-09 Drug product 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 8497258 2026-11-09 U-3820 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 8679545 2026-11-09 Drug product 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 8975243 2026-11-09 U-3820 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 9119863 2026-11-09 U-3820 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 11357859 2028-11-12 U-3820 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 10293052 2028-11-22 Drug product 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 9050368 2029-08-01 Drug product 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 8324192 2029-08-03 U-3820 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 11260064 2039-01-10 Drug product 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213976-001 11564934 2039-01-10 U-3820 2024-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213976-001 11197822 2026-11-09 Drug product 2024-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213976-001 11413296 2026-11-09 Drug product 2024-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213976-001 8497258 2026-11-09 U-3820 2024-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213976-001 8679545 2026-11-09 Drug product 2024-03-04 6a471c1ec25d…
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 Eohilia BUDESONIDE TAKEDA PHARMACEUTICALS AMERICA, INC. 56f2023a-69b2-4470-b4ad-af7ec1be527a 2025-02-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 213976 application number: NDA213976
Documents# Document, Submission type, Date table Document Submission type Date 79452 ORIG 2024-08-20 78503 SUPPL 2024-05-20 78489 SUPPL 2024-05-17 77475 ORIG 2024-02-12 77465 ORIG 2024-02-12