FDA.reportPublic FDA data

Application 219016

Type
NDA
Sponsor
JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDURANT PEDRILPIVIRINE HYDROCHLORIDETABLET, FOR SUSPENSION;ORALEQ 2.5MG BASEYesYes

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

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
N219016-001EDURANT PEDRILPIVIRINE HYDROCHLORIDEEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-15

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219016-001110651982037-10-23Drug product2024-05-02

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219016-001NP2027-03-15
N219016-001PED2027-09-15

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
2026-02-19 14:30 UTC2026-02N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD2024-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-158072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219016-001EDURANT PEDEQ 2.5MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2024-03-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219016-001110651982037-10-23Drug product2024-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219016-001110651982037-10-23Drug product2024-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219016-001110651982037-10-23Drug product2024-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219016-001110651982037-10-23Drug product2024-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N219016-001110651982037-10-23Drug product2024-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N219016-001110651982037-10-23Drug product2024-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N219016-001110651982037-10-23Drug product2024-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N219016-001110651982037-10-23Drug product2024-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N219016-001110651982037-10-23Drug product2024-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N219016-001110651982037-10-23Drug product2024-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N219016-001110651982037-10-23Drug product2024-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N219016-001110651982037-10-23Drug product2024-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N219016-001110651982037-10-23Drug product2024-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N219016-00171258792025-04-21U-3874Drug substance, Drug product2024-04-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05N219016-001110651982037-10-23Drug product2024-05-028072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219016-001110651982037-10-23Drug product2024-05-02a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N219016-001NP2027-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219016-001PED2027-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219016-001NP2027-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219016-001PED2027-09-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219016-001NP2027-03-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219016-001PED2027-09-15a50c72e98297…

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
EDURANTRILPIVIRINE HYDROCHLORIDEJanssen Products, LP03880372-2c68-45c6-a53a-f420c49541d62025-08-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 219016
application number: NDA219016

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80818ORIG 2025-01-07
77862ORIG 2024-03-18
77861ORIG 2024-03-18