Application 215206

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QULIPTAATOGEPANTTABLET;ORAL10MGYesNo
002QULIPTAATOGEPANTTABLET;ORAL30MGYesNo
003QULIPTAATOGEPANTTABLET;ORAL60MGYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215206-001QULIPTAATOGEPANT10MGTABLET / ORALRLD2021-09-28
N215206-002QULIPTAATOGEPANT30MGTABLET / ORALRLD2021-09-28
N215206-003QULIPTAATOGEPANT60MGTABLET / ORALRLD, RS2021-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215206-00194995452031-11-10U-3534Drug substance, Drug product2021-10-26
N215206-00198502462033-03-13Drug substance2021-10-26
N215206-001101178362035-01-30Drug product2021-10-26
N215206-00187540962035-09-28U-3534Drug substance, Drug product2021-10-26
N215206-001123835452039-06-06U-35342025-09-09
N215206-001120901482041-07-29U-35342025-09-09
N215206-001124655982042-09-27U-43552025-12-10
N215206-001126228972042-09-27U-45362026-06-09
N215206-001123502592043-02-27U-42342025-08-06
N215206-00294995452031-11-10U-3534Drug substance, Drug product2021-10-26
N215206-00298502462033-03-13Drug substance2021-10-26
N215206-002101178362035-01-30Drug product2021-10-26
N215206-00287540962035-09-28U-3534Drug substance, Drug product2021-10-26
N215206-002123835452039-06-06U-35342025-09-09
N215206-002120901482041-07-29U-35342025-09-09
N215206-002126228972042-09-27U-45362026-06-09
N215206-00394995452031-11-10U-3534Drug substance, Drug product2021-10-26
N215206-00398502462033-03-13Drug substance2021-10-26
N215206-003101178362035-01-30Drug product2021-10-26
N215206-00387540962035-09-28U-3534Drug substance, Drug product2021-10-26
N215206-003123835452039-06-06U-35342025-09-09
N215206-003120901482041-07-29U-35342024-10-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215206-001I-9092026-04-17
N215206-001NCE2026-09-28
N215206-002I-9092026-04-17
N215206-002NCE2026-09-28
N215206-003I-9092026-04-17
N215206-003NCE2026-09-28

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 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215206-002QULIPTA30MGTABLET / ORALRLD2021-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215206-003QULIPTA60MGTABLET / ORALRLD, RS2021-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215206-001QULIPTA10MGTABLET / ORALRLD2021-09-281e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 12 · 451 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N215206-00194995452031-11-10U-3534Drug substance, Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00198502462033-03-13Drug substance2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001101178362035-01-30Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00187540962035-09-28U-3534Drug substance, Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001123835452039-06-06U-35342025-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001120901482041-07-29U-35342025-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001124655982042-09-27U-43552025-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001126228972042-09-27U-45362026-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001123502592043-02-27U-42342025-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00294995452031-11-10U-3534Drug substance, Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00298502462033-03-13Drug substance2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002101178362035-01-30Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00287540962035-09-28U-3534Drug substance, Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002123835452039-06-06U-35342025-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002120901482041-07-29U-35342025-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002126228972042-09-27U-45362026-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00394995452031-11-10U-3534Drug substance, Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00398502462033-03-13Drug substance2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-003101178362035-01-30Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-00387540962035-09-28U-3534Drug substance, Drug product2021-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-003123835452039-06-06U-35342025-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-003120901482041-07-29U-35342024-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215206-00194995452031-11-10U-3534Drug substance, Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00187540962032-07-19U-3534Drug substance, Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00198502462033-03-13Drug substance2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-001101178362035-01-30Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-001123835452039-06-06U-35342025-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-001120901482041-07-29U-35342025-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-001124655982042-09-27U-43552025-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-001123502592043-02-27U-42342025-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00294995452031-11-10U-3534Drug substance, Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00287540962032-07-19U-3534Drug substance, Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00298502462033-03-13Drug substance2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-002101178362035-01-30Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-002123835452039-06-06U-35342025-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-002120901482041-07-29U-35342025-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00394995452031-11-10U-3534Drug substance, Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00387540962032-07-19U-3534Drug substance, Drug product2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-00398502462033-03-13Drug substance2021-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-003101178362035-01-30Drug product2021-10-26011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 171 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N215206-001I-9092026-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-001NCE2026-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002I-9092026-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-002NCE2026-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-003I-9092026-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N215206-003NCE2026-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215206-001I-9092026-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-001NCE2026-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-002I-9092026-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-002NCE2026-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-003I-9092026-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215206-003NCE2026-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-001I-9092026-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-001NCE2026-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-002I-9092026-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-002NCE2026-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-003I-9092026-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215206-003NCE2026-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215206-001I-9092026-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-001NCE2026-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-002I-9092026-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-002NCE2026-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-003I-9092026-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215206-003NCE2026-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-001I-9092026-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-001NCE2026-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-002I-9092026-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-002NCE2026-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-003I-9092026-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215206-003NCE2026-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-001I-9092026-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-001NCE2026-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-002I-9092026-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-002NCE2026-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-003I-9092026-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215206-003NCE2026-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-001I-9092026-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-001NCE2026-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-002I-9092026-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215206-002NCE2026-09-2803ed91905a0d…

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
QuliptaATOGEPANTAbbVie Inc.8c8ab8f4-32bd-497a-befa-70c8a51d8d522025-09-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 215206
application number: NDA215206
ndc (product): 0074-7095
ndc (product): 0074-7096
ndc (product): 0074-7094

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-7094QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7094QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7094QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7095QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7095QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7095QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7096QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7096QuliptaAtogepantAbbVie Inc.NDACurrent
0074-7096QuliptaAtogepantAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83627SUPPL 2025-10-02
83622SUPPL 2025-10-01
82549SUPPL 2025-06-12
82548SUPPL 2025-06-12
82533SUPPL 2025-06-11
81716SUPPL 2025-03-25
81697SUPPL 2025-03-24
74017SUPPL 2023-04-19
69181ORIG2021-11-01
68802ORIG2021-09-29
68801ORIG2021-09-29