Application 020685

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CRIXIVAN	INDINAVIR SULFATE	CAPSULE;ORAL	EQ 400MG BASE	Yes	Yes
003	CRIXIVAN	INDINAVIR SULFATE	CAPSULE;ORAL	EQ 200MG BASE	Yes	No
005	CRIXIVAN	INDINAVIR SULFATE	CAPSULE;ORAL	EQ 333MG BASE	No	No
006	CRIXIVAN	INDINAVIR SULFATE	CAPSULE;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020685-001	CRIXIVAN	INDINAVIR SULFATE	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13
N020685-003	CRIXIVAN	INDINAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13
N020685-005	CRIXIVAN	INDINAVIR SULFATE	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17
N020685-006	CRIXIVAN	INDINAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020685-001	CRIXIVAN	EQ 400MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020685-003	CRIXIVAN	EQ 200MG BASE	CAPSULE / ORAL	RLD	1996-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020685-005	CRIXIVAN	EQ 333MG BASE	CAPSULE / ORAL		1998-12-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020685-006	CRIXIVAN	EQ 100MG BASE	CAPSULE / ORAL		2000-04-19	`4b0b4de00fa7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020685-001	6689761	2021-02-10	U-554	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020685-003	6689761	2021-02-10	U-554	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020685-005	6689761	2021-02-10	U-554	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020685-006	6689761	2021-02-10	U-554	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020685-001	6689761	2021-02-10	U-554	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020685-003	6689761	2021-02-10	U-554	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020685-005	6689761	2021-02-10	U-554	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020685-006	6689761	2021-02-10	U-554	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020685-001	6689761	2021-02-10	U-554	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020685-003	6689761	2021-02-10	U-554	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020685-005	6689761	2021-02-10	U-554	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020685-006	6689761	2021-02-10	U-554	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020685-001	6689761	2021-02-10	U-554	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020685-003	6689761	2021-02-10	U-554	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020685-005	6689761	2021-02-10	U-554	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020685-006	6689761	2021-02-10	U-554	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020685-001	6689761	2021-02-10	U-554	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020685-003	6689761	2021-02-10	U-554	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020685-005	6689761	2021-02-10	U-554	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020685-006	6689761	2021-02-10	U-554	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020685-001	6689761	2021-02-10	U-554	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020685-003	6689761	2021-02-10	U-554	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020685-005	6689761	2021-02-10	U-554	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020685-006	6689761	2021-02-10	U-554	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020685-001	6689761	2021-02-10	U-554	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020685-003	6689761	2021-02-10	U-554	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020685-005	6689761	2021-02-10	U-554	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020685-006	6689761	2021-02-10	U-554	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020685-001	6689761	2021-02-10	U-554	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020685-003	6689761	2021-02-10	U-554	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020685-005	6689761	2021-02-10	U-554	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020685-006	6689761	2021-02-10	U-554	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020685-001	6689761	2021-02-10	U-554	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020685-003	6689761	2021-02-10	U-554	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020685-005	6689761	2021-02-10	U-554	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020685-006	6689761	2021-02-10	U-554	`ea99ee380514…`

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0571	CRIXIVAN	indinavir sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0006-0571	CRIXIVAN	indinavir sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0006-0571	CRIXIVAN	indinavir sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0006-0573	CRIXIVAN	indinavir sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0006-0573	CRIXIVAN	indinavir sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0006-0573	CRIXIVAN	indinavir sulfate	Merck Sharp & Dohme Corp.	NDA	Current
21695-366	CRIXIVAN	indinavir sulfate	Rebel Distributors Corp	NDA	Current
53808-0661	CRIXIVAN	indinavir sulfate	State of Florida DOH Central Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57688	ORIG	2019-02-15
45379	SUPPL	2016-09-20
45339	SUPPL	2016-09-20
13204	SUPPL	2015-04-07
3081	SUPPL	2015-04-03
35136	SUPPL	2014-07-28
3080	SUPPL	2014-07-28
25508	SUPPL	2012-02-27
13203	SUPPL	2012-02-22
3079	SUPPL	2011-06-17
13202	SUPPL	2010-11-19
13201	SUPPL	2010-05-03
3078	SUPPL	2010-04-28
3077	SUPPL	2009-11-19
13200	SUPPL	2009-10-21
35135	SUPPL	2009-01-02
3076	SUPPL	2008-12-18
13199	SUPPL	2008-06-05
35134	SUPPL	2008-04-23
25507	SUPPL	2008-04-22
25506	SUPPL	2008-04-18
41552	SUPPL	2007-09-26
41551	SUPPL	2007-09-26
41550	SUPPL	2007-09-26
41549	SUPPL	2007-09-26
41548	SUPPL	2007-09-26
20819	SUPPL	2007-09-26
13198	SUPPL	2007-07-24
3075	SUPPL	2007-07-24
3074	SUPPL	2006-12-28
13197	SUPPL	2006-12-14
3073	SUPPL	2006-08-11
13196	SUPPL	2006-08-09
25505	SUPPL	2006-01-20
13195	SUPPL	2006-01-13
13194	SUPPL	2004-12-29
3072	SUPPL	2004-12-29
25501	SUPPL	2004-05-07
13192	SUPPL	2004-05-07
13191	SUPPL	2004-05-07
3068	SUPPL	2004-05-07
41547	SUPPL	2004-05-06
35133	SUPPL	2004-01-15
25504	SUPPL	2004-01-14
35132	SUPPL	2003-06-22
3071	SUPPL	2003-06-22
20818	SUPPL	2003-04-25
13193	SUPPL	2002-09-19
3070	SUPPL	2002-09-19
35131	SUPPL	2002-06-20
35130	SUPPL	2002-06-20
35129	SUPPL	2002-06-20
25503	SUPPL	2002-06-20
25502	SUPPL	2002-06-20
3069	SUPPL	2002-01-25
25500	SUPPL	2001-03-21
41546	SUPPL	1998-12-17
41545	SUPPL	1997-02-19