Application 205395

Type: NDA
Sponsor: JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREZCOBIX	COBICISTAT; DARUNAVIR	TABLET;ORAL	150MG;800MG	Yes	Yes
002	PREZCOBIX	COBICISTAT; DARUNAVIR ETHANOLATE	TABLET;ORAL	150MG;EQ 675MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205395-001	PREZCOBIX	COBICISTAT; DARUNAVIR ETHANOLATE	150MG;EQ 800MG BASE	TABLET / ORAL		RLD, RS	2015-01-29
N205395-002	PREZCOBIX	COBICISTAT; DARUNAVIR ETHANOLATE	150MG;EQ 675MG BASE	TABLET / ORAL		RLD, RS	2025-03-21

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205395-001	7700645	2026-12-26		Drug substance, Drug product	2015-02-26
N205395-001	7700645*PED	2027-06-26		Pediatric extension
N205395-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-02-26
N205395-001	8148374	2029-09-03	U-2939	Drug substance, Drug product	2015-02-26
N205395-001	8148374	2029-09-03	U-4162	Drug substance, Drug product	2015-02-26
N205395-001	10039718	2032-10-06		Drug product	2018-09-05
N205395-002	7700645	2026-12-26		Drug substance, Drug product	2025-04-16
N205395-002	7700645*PED	2027-06-26		Pediatric extension
N205395-002	8148374	2029-09-03	U-4162	Drug substance, Drug product	2025-04-16
N205395-002	10039718	2032-10-06		Drug product	2025-04-16

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 2 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205395-001	PREZCOBIX	150MG;800MG	TABLET / ORAL	RLD, RS	2015-01-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205395-001	PREZCOBIX	150MG;EQ 800MG BASE	TABLET / ORAL	RLD, RS	2015-01-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205395-002	PREZCOBIX	150MG;EQ 675MG BASE	TABLET / ORAL	RLD, RS	2025-03-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 341 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N205395-001	7700645	2026-12-26		Drug substance, Drug product	2015-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-001	7700645*PED	2027-06-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-001	8148374	2029-09-03	U-4162	Drug substance, Drug product	2015-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-001	8148374	2029-09-03	U-2939	Drug substance, Drug product	2015-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-001	10039718	2032-10-06		Drug product	2018-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-002	7700645	2026-12-26		Drug substance, Drug product	2025-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-002	7700645*PED	2027-06-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-002	8148374	2029-09-03	U-4162	Drug substance, Drug product	2025-04-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N205395-002	10039718	2032-10-06		Drug product	2025-04-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N205395-001	7700645	2026-12-26		Drug substance, Drug product	2015-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-001	7700645*PED	2027-06-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-001	8148374	2029-09-03	U-4162	Drug substance, Drug product	2015-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-001	8148374	2029-09-03	U-2939	Drug substance, Drug product	2015-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-001	10039718	2032-10-06		Drug product	2018-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-002	7700645	2026-12-26		Drug substance, Drug product	2025-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-002	7700645*PED	2027-06-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-002	8148374	2029-09-03	U-4162	Drug substance, Drug product	2025-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205395-002	10039718	2032-10-06		Drug product	2025-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205395-001	7700645	2026-12-26		Drug substance, Drug product	2015-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-001	7700645*PED	2027-06-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-001	8148374	2029-09-03	U-4162	Drug substance, Drug product	2015-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-001	8148374	2029-09-03	U-2939	Drug substance, Drug product	2015-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-001	10039718	2032-10-06		Drug product	2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-002	7700645	2026-12-26		Drug substance, Drug product	2025-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-002	7700645*PED	2027-06-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-002	8148374	2029-09-03	U-4162	Drug substance, Drug product	2025-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205395-002	10039718	2032-10-06		Drug product	2025-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205395-001	7700645	2026-12-26		Drug substance, Drug product	2015-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-001	7700645*PED	2027-06-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-001	8148374	2029-09-03	U-4162	Drug substance, Drug product	2015-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-001	8148374	2029-09-03	U-2939	Drug substance, Drug product	2015-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-001	10039718	2032-10-06		Drug product	2018-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-002	7700645	2026-12-26		Drug substance, Drug product	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-002	7700645*PED	2027-06-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-002	8148374	2029-09-03	U-4162	Drug substance, Drug product	2025-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205395-002	10039718	2032-10-06		Drug product	2025-04-16	`011fe1cb6892…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREZCOBIX	DARUNAVIR ETHANOLATE AND COBICISTAT	Janssen Products, LP	9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205395 application number: NDA205395 ndc (product): 59676-575
PREZCOBIX	DARUNAVIR ETHANOLATE AND COBICISTAT	A-S Medication Solutions	16ca460a-3c89-4697-8f45-972615a2a518	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205395 application number: NDA205395 ndc (product): 50090-1723

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1723	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	A-S Medication Solutions	NDA	Current
50090-1723	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	A-S Medication Solutions	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
59676-575	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	Janssen Products LP	NDA	Current
70518-0714	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	REMEDYREPACK INC.	NDA	Current
70518-0714	PREZCOBIX	DARUNAVIR ETHANOLATE and COBICISTAT	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85274	SUPPL	2026-03-06
85205	SUPPL	2026-03-03
81711	SUPPL	2025-03-25
81703	SUPPL	2025-03-24
73936	SUPPL	2023-04-03
73922	SUPPL	2023-04-03
72456	SUPPL	2022-10-24
72436	SUPPL	2022-10-21
70777	SUPPL	2022-04-18
70770	SUPPL	2022-04-15
68202	SUPPL	2021-07-27
68190	SUPPL	2021-07-26
65755	SUPPL	2020-12-28
65720	SUPPL	2020-12-23
64186	SUPPL	2020-08-03
64172	SUPPL	2020-08-03
58944	SUPPL	2019-06-04
58886	SUPPL	2019-05-30
57540	SUPPL	2019-02-13
57375	SUPPL	2019-01-29
55445	SUPPL	2018-09-12
55423	SUPPL	2018-09-10
54457	SUPPL	2018-06-05
54437	SUPPL	2018-06-05
52428	SUPPL	2018-02-06
52427	SUPPL	2018-02-06
52125	SUPPL	2018-01-30
52124	SUPPL	2018-01-30
48723	SUPPL	2017-06-15
48720	SUPPL	2017-06-15
45523	SUPPL	2016-10-12
45414	SUPPL	2016-09-29
43486	ORIG	2016-06-15
24494	ORIG	2016-06-15
19642	SUPPL	2016-04-27
10443	SUPPL	2016-04-04
10442	ORIG	2015-02-02
40465	ORIG	2015-01-30