Home NDC 50090-2404 Breo Ellipta
Product NDC 50090-2404
11-digit product format 500902404
Labeler code 50090
Product ID 50090-2404_5b5dae35-bf7b-48f9-9e04-fa83ce96c135
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluticasone furoate and vilanterol trifenatate
Dosage form POWDER
Route RESPIRATORY (INHALATION)
Labeler A-S Medication Solutions
Application NDA204275
Marketing category NDA
Marketing start 2015-04-30
Marketing end 0000-00-00
Substance FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Active strength 200 ug/1; ug/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-2404-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-2404-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-2404-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-2404-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-2404-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-2404-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-2404-0 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-2404-0 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-2404-0 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-2404-0 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-2404-0 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2404-0 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-2404-0 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-2404-0 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-2404-0 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50090-2404-0 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50090-2404-0 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50090-2404-0 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50090-2404-0 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50090-2404-0 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50090-2404-0 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50090-2404-0 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204275-001 BREO ELLIPTA FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 N204275-002 BREO ELLIPTA FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 N204275-003 BREO ELLIPTA FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2023-05-12
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204275-001 8511304 2027-06-14 U-1424 Drug product 2013-09-06 N204275-001 8511304 2027-06-14 U-1691 Drug product 2013-09-06 N204275-001 8511304 2027-06-14 U-3623 Drug product 2013-09-06 N204275-001 8511304*PED 2027-12-14 Pediatric extension N204275-001 11116721 2029-02-26 U-1401 Drug product 2021-10-12 N204275-001 11116721 2029-02-26 U-1691 Drug product 2021-10-12 N204275-001 11116721 2029-02-26 U-3623 Drug product 2021-10-12 N204275-001 11116721*PED 2029-08-26 Pediatric extension N204275-001 8534281 2030-03-08 Drug product 2013-09-18 N204275-001 8534281*PED 2030-09-08 Pediatric extension N204275-001 8746242 2030-10-11 Drug product 2014-07-08 N204275-001 8746242*PED 2031-04-11 Pediatric extension N204275-002 8511304 2027-06-14 U-1691 Drug product 2015-05-07 N204275-002 8511304 2027-06-14 U-3623 Drug product 2015-05-07 N204275-002 8511304*PED 2027-12-14 Pediatric extension N204275-002 11116721 2029-02-26 U-1691 Drug product 2021-10-12 N204275-002 11116721 2029-02-26 U-3623 Drug product 2021-10-12 N204275-002 11116721*PED 2029-08-26 Pediatric extension N204275-002 8534281 2030-03-08 Drug product 2015-05-07 N204275-002 8534281*PED 2030-09-08 Pediatric extension N204275-002 8746242 2030-10-11 Drug product 2015-05-07 N204275-002 8746242*PED 2031-04-11 Pediatric extension N204275-003 8511304 2027-06-14 U-3623 Drug product 2023-06-09 N204275-003 8511304*PED 2027-12-14 Pediatric extension N204275-003 11116721 2029-02-26 U-3623 Drug product 2023-06-09 N204275-003 11116721*PED 2029-08-26 Pediatric extension N204275-003 8534281 2030-03-08 Drug product 2023-06-09 N204275-003 8534281*PED 2030-09-08 Pediatric extension N204275-003 8746242 2030-10-11 Drug product 2023-06-09 N204275-003 8746242*PED 2031-04-11 Pediatric extension
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 1 of 3 · 107 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 2026-08-18 06:07:40 2026-07 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2023-05-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2023-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204275-002 BREO ELLIPTA 0.2MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2015-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204275-003 BREO ELLIPTA 0.05MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD 2023-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204275-001 BREO ELLIPTA 0.1MG/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-05-10 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 45 · 1,785 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 N204275-001 8511304 2027-06-14 U-1691 Drug product 2013-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8511304 2027-06-14 U-1424 Drug product 2013-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8511304 2027-06-14 U-3623 Drug product 2013-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8511304*PED 2027-12-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 11116721 2029-02-26 U-1401 Drug product 2021-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 11116721 2029-02-26 U-3623 Drug product 2021-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 11116721 2029-02-26 U-1691 Drug product 2021-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 11116721*PED 2029-08-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8534281 2030-03-08 Drug product 2013-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8534281*PED 2030-09-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8746242 2030-10-11 Drug product 2014-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-001 8746242*PED 2031-04-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8511304 2027-06-14 U-3623 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8511304 2027-06-14 U-1691 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8511304*PED 2027-12-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 11116721 2029-02-26 U-3623 Drug product 2021-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 11116721 2029-02-26 U-1691 Drug product 2021-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 11116721*PED 2029-08-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8534281 2030-03-08 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8534281*PED 2030-09-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8746242 2030-10-11 Drug product 2015-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-002 8746242*PED 2031-04-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 8511304 2027-06-14 U-3623 Drug product 2023-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 8511304*PED 2027-12-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 11116721 2029-02-26 U-3623 Drug product 2023-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 11116721*PED 2029-08-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 8534281 2030-03-08 Drug product 2023-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 8534281*PED 2030-09-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 8746242 2030-10-11 Drug product 2023-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204275-003 8746242*PED 2031-04-11 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204275-001 8511304 2027-06-14 U-1691 Drug product 2013-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 8511304 2027-06-14 U-1424 Drug product 2013-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 8511304 2027-06-14 U-3623 Drug product 2013-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 8511304*PED 2027-12-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 11116721 2029-02-26 U-1401 Drug product 2021-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 11116721 2029-02-26 U-3623 Drug product 2021-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 11116721 2029-02-26 U-1691 Drug product 2021-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 11116721*PED 2029-08-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 8534281 2030-03-08 Drug product 2013-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204275-001 8534281*PED 2030-09-08 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 observed states.
FDA-Initiated Inactive NDC Indexing# 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.