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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N202022-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202022-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202022-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202022-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202022-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202022-001	7125879	2025-04-21	U-1740	Drug substance, Drug product	2011-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202022-001	7125879	2025-04-21	U-1153	Drug substance, Drug product	2011-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202022-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2011-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202022-001	7125879	2025-04-21	U-3353	Drug substance, Drug product	2011-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202022-001	7125879	2025-04-21	U-1740	Drug substance, Drug product	2011-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202022-001	7125879	2025-04-21	U-1153	Drug substance, Drug product	2011-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202022-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2011-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202022-001	7125879	2025-04-21	U-3353	Drug substance, Drug product	2011-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202022-001	7125879	2025-04-21	U-1740	Drug substance, Drug product	2011-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202022-001	7125879	2025-04-21	U-1153	Drug substance, Drug product	2011-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202022-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2011-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202022-001	7125879	2025-04-21	U-3353	Drug substance, Drug product	2011-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202022-001	7125879	2025-04-21	U-1740	Drug substance, Drug product	2011-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202022-001	7125879	2025-04-21	U-1153	Drug substance, Drug product	2011-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202022-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2011-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202022-001	7125879	2025-04-21	U-3353	Drug substance, Drug product	2011-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202022-001	7125879	2025-04-21	U-1740	Drug substance, Drug product	2011-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202022-001	7125879	2025-04-21	U-1153	Drug substance, Drug product	2011-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202022-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2011-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202022-001	7125879	2025-04-21	U-3353	Drug substance, Drug product	2011-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202022-001	7125879	2025-04-21	U-1740	Drug substance, Drug product	2011-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202022-001	7125879	2025-04-21	U-1153	Drug substance, Drug product	2011-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202022-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2011-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202022-001	7125879	2025-04-21	U-3353	Drug substance, Drug product	2011-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202022-001	7125879	2025-04-21	U-1307	Drug substance, Drug product	2011-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202022-001	7125879*PED	2025-10-21		Pediatric extension		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202022-001	8101629	2022-08-09		Drug product	2012-02-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202022-001	8080551	2023-04-11		Drug substance, Drug product	2012-01-12	`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N202022-001	NPP	2027-03-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202022-001	PED	2027-09-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202022-001	NPP	2027-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202022-001	PED	2027-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202022-001	NPP	2027-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202022-001	PED	2027-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202022-001	NPP	2027-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202022-001	PED	2027-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202022-001	NPP	2027-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202022-001	PED	2027-09-15	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	N202022-001	M-223	2021-02-01	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N202022-001	M-223	2021-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202022-001	M-223	2021-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202022-001	M-223	2021-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202022-001	M-223	2021-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202022-001	M-223	2021-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202022-001	M-223	2021-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202022-001	M-223	2021-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202022-001	M-223	2021-02-01	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202022-001	NPP	2027-03-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202022-001	PED	2027-09-15	`a50c72e98297…`

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77853	SUPPL	2024-04-09
77852	SUPPL	2024-04-09
77858	SUPPL	2024-03-18
77857	SUPPL	2024-03-18
72446	SUPPL	2022-10-21
72428	SUPPL	2022-10-20
70663	SUPPL	2022-03-30
70662	SUPPL	2022-03-30
70649	SUPPL	2022-03-30
70648	SUPPL	2022-03-30
70058	SUPPL	2022-02-03
70041	SUPPL	2022-02-01
66013	SUPPL	2021-01-28
65962	SUPPL	2021-01-22
58778	SUPPL	2019-05-17
58725	SUPPL	2019-05-15
52292	SUPPL	2018-02-02
52240	SUPPL	2018-02-01
49790	SUPPL	2017-09-19
49769	SUPPL	2017-09-18
9945	SUPPL	2015-08-28
19047	SUPPL	2015-08-27
32156	SUPPL	2015-05-11
40099	SUPPL	2015-05-07
9944	SUPPL	2014-05-06
40098	SUPPL	2014-05-02
40097	SUPPL	2013-06-25
9943	SUPPL	2013-06-21
32154	SUPPL	2012-12-11
19046	SUPPL	2012-12-10
40096	SUPPL	2012-08-15
32155	SUPPL	2012-08-15
44840	ORIG	2011-07-05
22867	ORIG	2011-07-05
32153	ORIG	2011-05-24
40095	ORIG	2011-05-23
51472	SUPPL	1900-01-01
51471	SUPPL	1900-01-01