Home Applications 022519 Application 022519
Type NDA
Sponsor HORIZON Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DUEXIS FAMOTIDINE; IBUPROFEN TABLET;ORAL 26.6MG;800MG 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 N022519-001 DUEXIS FAMOTIDINE; IBUPROFEN 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-04-23
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 N022519-001 8501228 2026-07-18 U-1196 2013-08-06
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 N022519-001 DUEXIS 26.6MG;800MG TABLET / ORAL AB RLD, RS 2011-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022519-001 DUEXIS 26.6MG;800MG TABLET / ORAL AB RLD, RS 2011-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022519-001 DUEXIS 26.6MG;800MG TABLET / ORAL AB RLD, RS 2011-04-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022519-001 DUEXIS 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2011-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 230 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 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022519-001 8067451 2026-07-18 U-1196 Drug product 2011-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022519-001 8309127 2026-07-18 Drug product 2012-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022519-001 8318202 2026-07-18 Drug product 2012-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022519-001 8449910 2026-07-18 Drug product 2013-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022519-001 8501228 2026-07-18 U-1196 2013-08-06 b8a1b40f171c…
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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70748-312 Ibuprofen and Famotidine Ibuprofen and Famotidine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 70748-312 Ibuprofen and Famotidine Ibuprofen and Famotidine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 70748-312 Ibuprofen and Famotidine Ibuprofen and Famotidine Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 75987-010 DUEXIS Ibuprofen and Famotidine Horizon Therapeutics USA, Inc. NDA Current 75987-010 DUEXIS Ibuprofen and Famotidine Horizon Pharma Inc. NDA Current 75987-010 DUEXIS Ibuprofen and Famotidine Horizon Medicines LLC NDA Current 75987-010 DUEXIS Ibuprofen and Famotidine Horizon Therapeutics USA, Inc. NDA Current 75987-010 DUEXIS Ibuprofen and Famotidine Horizon Therapeutics USA, Inc. NDA Current 75987-010 DUEXIS Ibuprofen and Famotidine Horizon Therapeutics USA, Inc. NDA Current