Application 202895

Type: NDA
Sponsor: JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREZISTA	DARUNAVIR	SUSPENSION;ORAL	100MG/ML	Yes	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202895-001	PREZISTA	DARUNAVIR	100MG/ML	SUSPENSION / ORAL		RLD, RS	2011-12-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202895-001	7700645	2026-12-26		Drug substance, Drug product	2012-01-13
N202895-001	7700645*PED	2027-06-26		Pediatric extension

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202895-001	PREZISTA	EQ 100MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202895-001	PREZISTA	EQ 100MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`1e350fbaab3a…`

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
PREZISTA	DARUNAVIR	Janssen Products LP	814301f9-c990-46a5-b481-2879a521a16f	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202895 application number: NDA202895 ndc (product): 59676-565

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current
59676-565	PREZISTA	darunavir	Janssen Products LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73940	SUPPL	2023-04-03
73926	SUPPL	2023-04-03
72459	SUPPL	2022-10-24
72442	SUPPL	2022-10-21
70776	SUPPL	2022-04-15
70773	SUPPL	2022-04-15
68402	SUPPL	2021-08-18
68206	SUPPL	2021-07-27
68189	SUPPL	2021-07-26
65756	SUPPL	2020-12-28
65718	SUPPL	2020-12-23
58960	SUPPL	2019-06-04
58882	SUPPL	2019-05-30
58069	SUPPL	2019-03-25
58063	SUPPL	2019-03-22
57561	SUPPL	2019-02-13
57405	SUPPL	2019-02-01
55440	SUPPL	2018-09-12
52424	SUPPL	2018-02-06
52098	SUPPL	2018-01-30
48896	SUPPL	2017-07-05
48792	SUPPL	2017-06-22
45336	SUPPL	2016-09-20
45308	SUPPL	2016-09-15
40240	SUPPL	2016-06-21
10134	SUPPL	2016-06-21
19400	SUPPL	2015-05-29
32338	SUPPL	2015-05-28
40239	SUPPL	2015-04-02
10133	SUPPL	2015-04-01
40238	SUPPL	2014-04-08
32337	SUPPL	2014-04-08
19399	SUPPL	2013-11-08
10132	SUPPL	2013-11-08
19396	SUPPL	2013-04-29
32334	SUPPL	2013-04-25
40237	SUPPL	2013-02-26
32336	SUPPL	2013-02-26
19398	SUPPL	2013-02-06
19397	SUPPL	2013-02-06
32335	SUPPL	2013-02-04
10131	SUPPL	2013-02-04
40236	SUPPL	2012-11-15
10130	SUPPL	2012-11-14
24423	ORIG	2012-09-06
22903	ORIG	2012-09-06
10129	SUPPL	2012-06-07
40235	SUPPL	2012-06-05
40234	SUPPL	2012-03-15
32333	SUPPL	2012-02-29
10128	ORIG	2011-12-27
40233	ORIG	2011-12-23
51507	ORIG	2007-08-16
51505	ORIG	2006-11-17
63517	ORIG	1900-01-01
63516	ORIG	1900-01-01
63515	ORIG	1900-01-01
52600	ORIG	1900-01-01