Home Applications 202022 Application 202022
Type NDA
Sponsor JANSSEN PRODS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EDURANT RILPIVIRINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202022-001 EDURANT RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB RLD, RS 2011-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202022-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N202022-001 NPP 2027-03-15 N202022-001 PED 2027-09-15
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.
Product history page 1 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL AB RLD, RS 2011-05-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL AB RLD, RS 2011-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL AB RLD, RS 2011-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL AB RLD, RS 2011-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202022-001 EDURANT EQ 25MG BASE TABLET / ORAL RLD, RS 2011-05-20 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 4 of 7 · 256 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2021-12-28 21:50 UTC 2021-12 N202022-001 7125879 2025-04-21 U-3068 Drug substance, Drug product 2011-06-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202022-001 7125879 2025-04-21 U-1307 Drug substance, Drug product 2011-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 6838464 2021-02-26 Drug substance, Drug product 2011-06-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 8101629 2022-08-09 Drug product 2012-02-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 8080551 2023-04-11 Drug substance, Drug product 2012-01-12 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 7638522 2023-04-14 Drug product 2011-06-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 7125879 2025-04-21 U-1740 Drug substance, Drug product 2011-06-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 7125879 2025-04-21 U-1153 Drug substance, Drug product 2011-06-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 7125879 2025-04-21 U-3068 Drug substance, Drug product 2011-06-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202022-001 7125879 2025-04-21 U-1307 Drug substance, Drug product 2011-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202022-001 6838464 2021-02-26 Drug substance, Drug product 2011-06-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202022-001 8101629 2022-08-09 Drug product 2012-02-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202022-001 8080551 2023-04-11 Drug substance, Drug product 2012-01-12 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202022-001 7638522 2023-04-14 Drug product 2011-06-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202022-001 7125879 2025-04-21 U-1740 Drug substance, Drug product 2011-06-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202022-001 7125879 2025-04-21 U-1153 Drug substance, Drug product 2011-06-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202022-001 7125879 2025-04-21 U-1307 Drug substance, Drug product 2011-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202022-001 6838464 2021-02-26 Drug substance, Drug product 2011-06-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202022-001 8101629 2022-08-09 Drug product 2012-02-21 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202022-001 8080551 2023-04-11 Drug substance, Drug product 2012-01-12 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202022-001 7638522 2023-04-14 Drug product 2011-06-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202022-001 7125879 2025-04-21 U-1740 Drug substance, Drug product 2011-06-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202022-001 7125879 2025-04-21 U-1153 Drug substance, Drug product 2011-06-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202022-001 7125879 2025-04-21 U-1307 Drug substance, Drug product 2011-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202022-001 6838464 2021-02-26 Drug substance, Drug product 2011-06-11 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202022-001 8101629 2022-08-09 Drug product 2012-02-21 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202022-001 8080551 2023-04-11 Drug substance, Drug product 2012-01-12 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202022-001 7638522 2023-04-14 Drug product 2011-06-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202022-001 7125879 2025-04-21 U-1740 Drug substance, Drug product 2011-06-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202022-001 7125879 2025-04-21 U-1153 Drug substance, Drug product 2011-06-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202022-001 7125879 2025-04-21 U-1307 Drug substance, Drug product 2011-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202022-001 7067522 2019-12-20 Drug substance, Drug product 2011-06-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 6838464 2021-02-26 Drug substance, Drug product 2011-06-11 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 8101629 2022-08-09 Drug product 2012-02-21 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 8080551 2023-04-11 Drug substance, Drug product 2012-01-12 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 7638522 2023-04-14 Drug product 2011-06-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 7125879 2025-04-21 U-1307 Drug substance, Drug product 2011-06-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 7125879 2025-04-21 U-1740 Drug substance, Drug product 2011-06-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202022-001 7125879 2025-04-21 U-1153 Drug substance, Drug product 2011-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202022-001 7067522 2019-12-20 Drug substance, Drug product 2011-06-16 b00525d2431f…
Observed Orange Book exclusivity history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EDURANT RILPIVIRINE HYDROCHLORIDE Janssen Products, LP 03880372-2c68-45c6-a53a-f420c49541d6 2025-08-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 202022 application number: NDA202022 ndc (product): 59676-278
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59676-278 EDURANT rilpivirine hydrochloride Janssen Products, LP NDA Current 59676-278 EDURANT rilpivirine hydrochloride Janssen Products, LP NDA Current 59676-278 EDURANT rilpivirine hydrochloride Janssen Products, LP NDA Current 59676-278 EDURANT rilpivirine hydrochloride Janssen Products, LP NDA Current 59676-278 EDURANT rilpivirine hydrochloride Janssen Products, LP NDA Current 59676-278 EDURANT rilpivirine hydrochloride Janssen Products, LP NDA Current