Application 214120

Type
NDA
Sponsor
CELGENE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONUREGAZACITIDINETABLET;ORAL200MGNoNo
002ONUREGAZACITIDINETABLET; ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214120-001ONUREGAZACITIDINE200MGTABLET / ORALRLD2020-09-01
N214120-002ONUREGAZACITIDINE300MGTABLET / ORALRLD, RS2020-09-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214120-001115714362029-05-14Drug product2023-02-10
N214120-001120534822029-05-14U-29502024-08-28
N214120-00188466282030-06-03U-2950Drug product2020-09-29
N214120-002115714362029-05-14Drug product2023-02-10
N214120-002120534822029-05-14U-29502024-08-28
N214120-00288466282030-06-03U-2950Drug product2020-09-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214120-001ODE-3202027-09-01
N214120-002ODE-3202027-09-01

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-001ONUREG200MGTABLET / ORALRLD2020-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214120-001ONUREG200MGTABLET / ORALRLD2020-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-001ONUREG200MGTABLET / ORALRLD2020-09-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-001ONUREG200MGTABLET / ORALRLD2020-09-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214120-001ONUREG200MGTABLET / ORALRLD2020-09-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214120-001ONUREG200MGTABLET / ORALRLD2020-09-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214120-001ONUREG200MGTABLET / ORALRLD2020-09-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214120-001ONUREG200MGTABLET / ORALRLD2020-09-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214120-001ONUREG200MGTABLET / ORALRLD2020-09-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214120-001ONUREG200MGTABLET / ORALRLD2020-09-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214120-001ONUREG200MGTABLET / ORALRLD2020-09-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214120-001ONUREG200MGTABLET / ORALRLD2020-09-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N214120-001ONUREG200MGTABLET / ORALRLD2020-09-0187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N214120-002ONUREG300MGTABLET / ORALRLD, RS2020-09-0187673890dc5c…

Observed Orange Book patent history#

Patent history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214120-001115714362029-05-14Drug product2023-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-001120534822029-05-14U-29502024-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-00188466282030-06-03U-2950Drug product2020-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-002115714362029-05-14Drug product2023-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-002120534822029-05-14U-29502024-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-00288466282030-06-03U-2950Drug product2020-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-001115714362029-05-14Drug product2023-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-001120534822029-05-14U-29502024-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-00188466282030-06-03U-2950Drug product2020-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-002115714362029-05-14Drug product2023-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-002120534822029-05-14U-29502024-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-00288466282030-06-03U-2950Drug product2020-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N214120-001115714362029-05-14Drug product2023-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-001120534822029-05-14U-29502024-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-00188466282030-06-03U-2950Drug product2020-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-002115714362029-05-14Drug product2023-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-002120534822029-05-14U-29502024-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-00288466282030-06-03U-2950Drug product2020-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-001115714362029-05-14Drug product2023-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-001120534822029-05-14U-29502024-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-00188466282030-06-03U-2950Drug product2020-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-002115714362029-05-14Drug product2023-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-002120534822029-05-14U-29502024-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-00288466282030-06-03U-2950Drug product2020-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-001115714362029-05-14Drug product2023-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-001120534822029-05-14U-29502024-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-00188466282030-06-03U-2950Drug product2020-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-002115714362029-05-14Drug product2023-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-002120534822029-05-14U-29502024-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-00288466282030-06-03U-2950Drug product2020-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-001115714362029-05-14Drug product2023-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-001120534822029-05-14U-29502024-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-00188466282030-06-03U-2950Drug product2020-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-002115714362029-05-14Drug product2023-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-002120534822029-05-14U-29502024-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-00288466282030-06-03U-2950Drug product2020-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-001115714362029-05-14Drug product2023-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-001120534822029-05-14U-29502024-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-00188466282030-06-03U-2950Drug product2020-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-002115714362029-05-14Drug product2023-02-102680178bc6a6…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N214120-001ODE-3202027-09-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214120-002ODE-3202027-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-001ODE-3202027-09-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214120-002ODE-3202027-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214120-001ODE-3202027-09-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214120-002ODE-3202027-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-001ODE-3202027-09-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214120-002ODE-3202027-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-001ODE-3202027-09-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214120-002ODE-3202027-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-001ODE-3202027-09-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214120-002ODE-3202027-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-001ODE-3202027-09-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214120-002ODE-3202027-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214120-001ODE-3202027-09-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214120-002ODE-3202027-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214120-001ODE-3202027-09-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214120-002ODE-3202027-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214120-001ODE-3202027-09-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N214120-002ODE-3202027-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214120-001ODE-3202027-09-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214120-002ODE-3202027-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214120-001ODE-3202027-09-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214120-002ODE-3202027-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214120-001ODE-3202027-09-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214120-002ODE-3202027-09-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214120-001ODE-3202027-09-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214120-002ODE-3202027-09-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214120-001NP2023-09-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214120-001ODE-3202027-09-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214120-002NP2023-09-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214120-002ODE-3202027-09-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214120-001NP2023-09-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214120-001ODE-3202027-09-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214120-002NP2023-09-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214120-002ODE-3202027-09-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214120-001NP2023-09-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214120-001ODE-3202027-09-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214120-002NP2023-09-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214120-002ODE-3202027-09-014b0b4de00fa7…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONUREGAZACITIDINECelgene Corporation0e95e33f-8aba-4f19-b332-2416580d358b2026-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 214120
application number: NDA214120
ndc (product): 59572-730
ndc (product): 59572-740

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59572-730ONUREGazacitidineCelgene CorporationNDACurrent
59572-730ONUREGazacitidineCelgene CorporationNDACurrent
59572-730ONUREGazacitidineCelgene CorporationNDACurrent
59572-730ONUREGazacitidineCelgene CorporationNDACurrent
59572-730ONUREGazacitidineCelgene CorporationNDACurrent
59572-740ONUREGazacitidineCelgene CorporationNDACurrent
59572-740ONUREGazacitidineCelgene CorporationNDACurrent
59572-740ONUREGazacitidineCelgene CorporationNDACurrent
59572-740ONUREGazacitidineCelgene CorporationNDACurrent
59572-740ONUREGazacitidineCelgene CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85677SUPPL 2026-04-14
85673SUPPL 2026-04-10
69839SUPPL2022-01-11
69830SUPPL2022-01-11
66059ORIG2021-02-02
64474ORIG2020-09-02
64467ORIG2020-09-01