FDA.reportPublic FDA data

Application 210910

Type
NDA
Sponsor
REDHILL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AEMCOLORIFAMYCIN SODIUMTABLET, DELAYED RELEASE;ORALEQ 194MG BASEYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210910-001AEMCOLORIFAMYCIN SODIUMEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD2018-11-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N210910-001NCE2023-11-16
N210910-001GAIN2028-11-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N210910-001AEMCOLOEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2018-11-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210910-001AEMCOLOEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2018-11-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210910-001AEMCOLOEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2018-11-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N210910-001AEMCOLOEQ 194MG BASETABLET, DELAYED RELEASE / ORALRLD2018-11-16a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210910-00182631202025-05-03Drug product2018-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210910-00184864462025-05-03Drug product2018-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210910-00185299452025-05-03Drug product2018-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210910-00187419482025-05-03U-2448Drug product2018-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210910-00182631202025-05-03Drug product2018-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210910-00184864462025-05-03Drug product2018-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210910-00185299452025-05-03Drug product2018-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210910-00187419482025-05-03U-2448Drug product2018-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210910-00182631202025-05-03Drug product2018-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210910-00184864462025-05-03Drug product2018-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210910-00185299452025-05-03Drug product2018-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210910-00187419482025-05-03U-2448Drug product2018-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210910-00182631202025-05-03Drug product2018-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210910-00184864462025-05-03Drug product2018-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210910-00185299452025-05-03Drug product2018-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210910-00187419482025-05-03U-2448Drug product2018-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210910-00182631202025-05-03Drug product2018-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210910-00184864462025-05-03Drug product2018-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210910-00185299452025-05-03Drug product2018-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210910-00187419482025-05-03U-2448Drug product2018-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210910-00182631202025-05-03Drug product2018-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210910-00184864462025-05-03Drug product2018-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210910-00185299452025-05-03Drug product2018-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210910-00187419482025-05-03U-2448Drug product2018-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210910-00182631202025-05-03Drug product2018-12-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210910-00184864462025-05-03Drug product2018-12-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210910-00185299452025-05-03Drug product2018-12-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210910-00187419482025-05-03U-2448Drug product2018-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210910-00182631202025-05-03Drug product2018-12-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210910-00184864462025-05-03Drug product2018-12-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210910-00185299452025-05-03Drug product2018-12-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210910-00187419482025-05-03U-2448Drug product2018-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210910-00182631202025-05-03Drug product2018-12-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N210910-00184864462025-05-03Drug product2018-12-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N210910-00185299452025-05-03Drug product2018-12-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N210910-00187419482025-05-03U-2448Drug product2018-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210910-00182631202025-05-03Drug product2018-12-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210910-00184864462025-05-03Drug product2018-12-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210910-00185299452025-05-03Drug product2018-12-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210910-00187419482025-05-03U-2448Drug product2018-12-0679d66fd596c7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N210910-001NCE2023-11-16c2088c7a36db…
2026-10-15 13:18:302026-09N210910-001GAIN2028-11-16c2088c7a36db…
2026-09-14 22:38:342026-08N210910-001NCE2023-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N210910-001GAIN2028-11-1684e616aacf4f…
2026-08-18 06:07:402026-07N210910-001NCE2023-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N210910-001GAIN2028-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210910-001NCE2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210910-001GAIN2028-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210910-001NCE2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210910-001GAIN2028-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210910-001NCE2023-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210910-001GAIN2028-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210910-001NCE2023-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210910-001GAIN2028-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210910-001NCE2023-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210910-001GAIN2028-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210910-001NCE2023-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210910-001GAIN2028-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210910-001NCE2023-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210910-001GAIN2028-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210910-001NCE2023-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210910-001GAIN2028-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210910-001NCE2023-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210910-001GAIN2028-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210910-001NCE2023-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N210910-001GAIN2028-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210910-001NCE2023-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210910-001GAIN2028-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210910-001NCE2023-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210910-001GAIN2028-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210910-001NCE2023-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210910-001GAIN2028-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210910-001NCE2023-11-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N210910-001GAIN2028-11-168072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210910-001NCE2023-11-166a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210910-001GAIN2028-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210910-001NCE2023-11-161c564ffb4f44…
2024-02-18 07:12 UTC2024-02N210910-001GAIN2028-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210910-001NCE2023-11-16ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N210910-001GAIN2028-11-16ea1830bbd6c7…

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57841-1200AemcoloRifamycinRedHill Biopharma LtdNDACurrent
57841-1200AemcoloRifamycinRedHill Biopharma LtdNDACurrent
57841-1201AemcoloRifamycinRedHill Biopharma LtdNDACurrent
57841-1201AemcoloRifamycinRedHill Biopharma LtdNDACurrent
71068-001AemcoloRifamycinAries Pharmaceuticals IncNDACurrent
71068-001AemcoloRifamycinAries Pharmaceuticals IncNDACurrent
71068-001AemcoloRifamycinAries Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59331SUPPL2019-07-15
56983ORIG2018-12-21
56517ORIG2018-11-20
56503ORIG2018-11-19