FDA.reportPublic FDA data

Application 217202

Type
NDA
Sponsor
AOP HLTH US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAPIBLYKLANDIOLOL HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 280MG BASE/VIALYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N217202-001RAPIBLYKLANDIOLOL HYDROCHLORIDEEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217202-001107225162034-04-25U-42352025-08-14

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217202-001NPP2029-02-13
N217202-001NCE2029-11-22

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-222680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217202-001RAPIBLYKEQ 280MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2024-11-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217202-001107225162034-04-25U-42352025-08-1484e616aacf4f…
2026-08-18 06:07:402026-07N217202-001107225162034-04-25U-42352025-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217202-001107225162034-04-25U-42352025-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217202-001107225162034-04-25U-42352025-08-1431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217202-001107225162034-04-25U-42352025-08-14a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217202-001NPP2029-02-1384e616aacf4f…
2026-09-14 22:38:342026-08N217202-001NCE2029-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N217202-001NPP2029-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217202-001NCE2029-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217202-001NCE2029-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217202-001NCE2029-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N217202-001NCE2029-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217202-001NCE2029-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217202-001NCE2029-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217202-001NCE2029-11-2203ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217202-001NPP2029-02-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217202-001NCE2029-11-22a50c72e98297…

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
RAPIBLYKLANDIOLOLAOP Orphan Pharmaceuticals GmbH27e7f20f-78a4-f1a9-e063-6394a90ae4652026-06-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 217202
application number: NDA217202

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85072SUPPL 2026-02-18
85057SUPPL 2026-02-18
80659ORIG 2024-12-20
80426ORIG 2024-11-26
80329ORIG 2024-11-25