Application 211765

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UBRELVYUBROGEPANTTABLET;ORAL50MGYesNo
002UBRELVYUBROGEPANTTABLET;ORAL100MGYesYes

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
N211765-001UBRELVYUBROGEPANT50MGTABLET / ORALRLD2019-12-23
N211765-002UBRELVYUBROGEPANT100MGTABLET / ORALRLD, RS2019-12-23

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211765-00194995452031-11-10U-2718Drug substance, Drug product2020-01-21
N211765-00198334482031-11-10U-27182020-01-21
N211765-00187540962032-07-19U-2717Drug substance, Drug product2020-01-21
N211765-00189122102033-12-23Drug substance, Drug product2020-01-21
N211765-001101178362035-01-30Drug product2020-01-21
N211765-001119257092035-01-30Drug product2024-04-10
N211765-001121680042035-01-30Drug product2025-01-15
N211765-001122204082035-01-30Drug product2025-03-12
N211765-001123109532035-01-30Drug product2025-06-25
N211765-001124586322035-01-30Drug product2025-11-04
N211765-001124586332035-01-30Drug product2025-11-04
N211765-001117175152041-12-22U-36772023-09-07
N211765-001118575422041-12-22U-37862024-01-31
N211765-001121940302041-12-22U-41212025-02-11
N211765-001121940302041-12-22U-41222025-02-11
N211765-001123297502041-12-22U-42132025-07-16
N211765-00294995452031-11-10U-2718Drug substance, Drug product2020-01-21
N211765-00298334482031-11-10U-27182020-01-21
N211765-00287540962032-07-19U-2717Drug substance, Drug product2020-01-21
N211765-00289122102033-12-23Drug substance, Drug product2020-01-21
N211765-002101178362035-01-30Drug product2020-01-21
N211765-002119257092035-01-30Drug product2024-04-10
N211765-002121680042035-01-30Drug product2025-01-15
N211765-002122204082035-01-30Drug product2025-03-12
N211765-002123109532035-01-30Drug product2025-06-25
N211765-002124586322035-01-30Drug product2025-11-04
N211765-002124586332035-01-30Drug product2025-11-04
N211765-002120704502041-12-22U-39922024-09-25

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 UTC2026-02N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211765-001UBRELVY50MGTABLET / ORALRLD2019-12-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211765-002UBRELVY100MGTABLET / ORALRLD, RS2019-12-2387673890dc5c…

Observed Orange Book patent history#

Patent history page 1 of 13 · 503 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N211765-00194995452031-11-10U-2718Drug substance, Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00198334482031-11-10U-27182020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00187540962032-07-19U-2717Drug substance, Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00189122102033-12-23Drug substance, Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001101178362035-01-30Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001119257092035-01-30Drug product2024-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001121680042035-01-30Drug product2025-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001122204082035-01-30Drug product2025-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001123109532035-01-30Drug product2025-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001124586322035-01-30Drug product2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001124586332035-01-30Drug product2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001117175152041-12-22U-36772023-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001118575422041-12-22U-37862024-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001121940302041-12-22U-41212025-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001121940302041-12-22U-41222025-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-001123297502041-12-22U-42132025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00294995452031-11-10U-2718Drug substance, Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00298334482031-11-10U-27182020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00287540962032-07-19U-2717Drug substance, Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-00289122102033-12-23Drug substance, Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002101178362035-01-30Drug product2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002119257092035-01-30Drug product2024-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002121680042035-01-30Drug product2025-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002122204082035-01-30Drug product2025-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002123109532035-01-30Drug product2025-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002124586322035-01-30Drug product2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002124586332035-01-30Drug product2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211765-002120704502041-12-22U-39922024-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-00194995452031-11-10U-2718Drug substance, Drug product2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-00198334482031-11-10U-27182020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-00187540962032-07-19U-2717Drug substance, Drug product2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-00189122102033-12-23Drug substance, Drug product2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001101178362035-01-30Drug product2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001119257092035-01-30Drug product2024-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001121680042035-01-30Drug product2025-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001122204082035-01-30Drug product2025-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001123109532035-01-30Drug product2025-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001124586322035-01-30Drug product2025-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001124586332035-01-30Drug product2025-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211765-001117175152041-12-22U-36772023-09-0731067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211765-001NCE2024-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211765-002NCE2024-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211765-001NCE2024-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211765-002NCE2024-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211765-001NCE2024-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211765-002NCE2024-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211765-001NCE2024-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211765-002NCE2024-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211765-001NCE2024-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N211765-002NCE2024-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211765-001NCE2024-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211765-002NCE2024-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211765-001NCE2024-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211765-002NCE2024-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211765-001NCE2024-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211765-002NCE2024-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211765-001NCE2024-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N211765-002NCE2024-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211765-001NCE2024-12-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211765-002NCE2024-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211765-001NCE2024-12-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N211765-002NCE2024-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211765-001NCE2024-12-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N211765-002NCE2024-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211765-001NCE2024-12-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N211765-002NCE2024-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211765-001NCE2024-12-23782e0a99824c…
2021-12-28 21:50 UTC2021-12N211765-002NCE2024-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211765-001NCE2024-12-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211765-002NCE2024-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N211765-001NCE2024-12-235aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N211765-002NCE2024-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211765-001NCE2024-12-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N211765-002NCE2024-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211765-001NCE2024-12-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N211765-002NCE2024-12-23c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211765-001NCE2024-12-236a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211765-002NCE2024-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211765-001NCE2024-12-231c564ffb4f44…
2024-02-18 07:12 UTC2024-02N211765-002NCE2024-12-231c564ffb4f44…

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
UBRELVYUBROGEPANTAllergan, Inc.fd9f9458-fd96-4688-be3f-f77b3d1af6ab2025-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 211765
application number: NDA211765
ndc (product): 0023-6498
ndc (product): 0023-6501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6498UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent
0023-6501UBRELVYubrogepantAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82554SUPPL 2025-06-13
82477SUPPL 2025-06-06
81712SUPPL 2025-03-25
81699SUPPL 2025-03-24
73578SUPPL 2023-02-21
73555SUPPL 2023-02-17
66481SUPPL2021-03-04
61608ORIG2020-01-22
61456ORIG2019-12-26
61434ORIG2019-12-23