Home Applications 208294 Application 208294
Type NDA
Sponsor ASTRAZENECA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BEVESPI AEROSPHERE FORMOTEROL FUMARATE; GLYCOPYRROLATE AEROSOL, METERED;INHALATION 0.0048MG/INH;0.0090MG/INH Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N208294-001 BEVESPI AEROSPHERE FORMOTEROL FUMARATE; GLYCOPYRROLATE 0.0048MG/INH;0.0090MG/INH AEROSOL, METERED / INHALATION RLD, RS 2016-04-25
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 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 N208294-001 9463161 2030-05-28 U-2889 Drug product 2016-10-25 N208294-001 8815258 2031-03-17 U-2889 2016-05-20
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 · 44 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 2022-10-28 04:53 UTC 2022-10 N208294-001 BEVESPI AEROSPHERE 0.0048MG/INH;0.0090MG/INH AEROSOL, METERED / INHALATION RLD, RS 2016-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208294-001 BEVESPI AEROSPHERE 0.0048MG/INH;0.0090MG/INH AEROSOL, METERED / INHALATION RLD, RS 2016-04-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208294-001 BEVESPI AEROSPHERE 0.0048MG/INH;0.0090MG/INH AEROSOL, METERED / INHALATION RLD, RS 2016-04-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208294-001 BEVESPI AEROSPHERE 0.0048MG/INH;0.0090MG/INH AEROSOL, METERED / INHALATION RLD, RS 2016-04-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 304 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 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208294-001 9463161 2030-05-28 U-2889 Drug product 2016-10-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208294-001 8815258 2031-03-17 U-2889 2016-05-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208294-001 9463161 2030-05-28 U-2889 Drug product 2016-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208294-001 8815258 2031-03-17 U-2889 2016-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208294-001 9463161 2030-05-28 U-2889 Drug product 2016-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208294-001 8815258 2031-03-17 U-2889 2016-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208294-001 9463161 2030-05-28 U-2889 Drug product 2016-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208294-001 8815258 2031-03-17 U-2889 2016-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 9463161 2030-05-28 U-2889 Drug product 2016-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208294-001 8815258 2031-03-17 U-2889 2016-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208294-001 10716753 2030-05-28 U-2889 Drug product 2020-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208294-001 8324266 2030-05-28 U-2889 2016-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208294-001 8703806 2030-05-28 U-2889 2016-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208294-001 8808713 2030-05-28 U-2889 Drug product 2016-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208294-001 9415009 2030-05-28 U-2889 2016-09-08 6a471c1ec25d…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N208294-001 NP 2019-04-25 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N208294-001 NP 2019-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208294-001 NP 2019-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208294-001 NP 2019-04-25 ea99ee380514…
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-4600 BEVESPI AEROSPHERE Glycopyrrolate and formoterol fumarate AstraZeneca Pharmaceuticals LP NDA Current 0310-4600 BEVESPI AEROSPHERE Glycopyrrolate and formoterol fumarate AstraZeneca Pharmaceuticals LP NDA Current 0310-4600 BEVESPI AEROSPHERE Glycopyrrolate and formoterol fumarate AstraZeneca Pharmaceuticals LP NDA Current 0310-4600 BEVESPI AEROSPHERE Glycopyrrolate and formoterol fumarate AstraZeneca Pharmaceuticals LP NDA Current 0310-4600 BEVESPI AEROSPHERE Glycopyrrolate and formoterol fumarate AstraZeneca Pharmaceuticals LP NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65170 SUPPL 2020-11-09 65165 SUPPL 2020-11-09 58939 SUPPL 2019-06-04 58895 SUPPL 2019-05-30 52884 ORIG 2018-03-09 32905 ORIG 2016-04-27 19991 ORIG 2016-04-27