Application 021360

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUSTIVA	EFAVIRENZ	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	SUSTIVA	EFAVIRENZ	TABLET;ORAL	600MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021360-001	SUSTIVA	EFAVIRENZ	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01
N021360-002	SUSTIVA	EFAVIRENZ	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021360-002	SUSTIVA	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021360-002	SUSTIVA	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021360-002	SUSTIVA	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021360-002	SUSTIVA	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021360-002	SUSTIVA	600MG	TABLET / ORAL		RLD	2002-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021360-002	SUSTIVA	600MG	TABLET / ORAL	AB	RLD, RS	2002-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021360-002	SUSTIVA	600MG	TABLET / ORAL	AB	RLD, RS	2002-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021360-002	SUSTIVA	600MG	TABLET / ORAL	AB	RLD, RS	2002-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	2002-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021360-002	SUSTIVA	600MG	TABLET / ORAL	AB	RLD, RS	2002-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021360-001	SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-02-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021360-002	SUSTIVA	600MG	TABLET / ORAL	AB	RLD, RS	2002-02-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021360-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021360-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021360-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021360-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021360-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021360-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021360-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021360-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021360-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021360-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021360-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021360-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021360-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	N021360-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021360-002	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Efavirenz	EFAVIRENZ	Macleods Pharmaceuticals Limited	13ca3456-e5bf-4bb1-af95-b1378658a358	2024-06-28	Warnings, Adverse reactions	Name fallback generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Cipla USA Inc.	92603fa5-7a2c-4bfb-9a70-aadb4fba952c	2024-03-31	Warnings, Adverse reactions	Name fallback generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Aurobindo Pharma Limited	4c57ad7f-321a-46c8-851a-c895466eb8e1	2023-12-29	Warnings, Adverse reactions	Name fallback generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Aurobindo Pharma Limited	c5eedb5d-4cab-4056-a14a-ffdf67701355	2023-12-29	Warnings, Adverse reactions	Name fallback generic name: EFAVIRENZ
Efavirenz	EFAVIRENZ	Camber Pharmaceuticals, Inc.	6d625901-fef2-4c93-9619-f8991d65413d	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: EFAVIRENZ
EFAVIRENZ	EFAVIRENZ	XLCare Pharmaceuticals Inc.	966b815d-1d78-4b54-8f00-c5a0b67c78be	2023-01-12	Warnings, Adverse reactions	Name fallback generic name: EFAVIRENZ

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
0056-0510	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0510	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0510	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0510	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0510	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0510	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
70518-0482	SUSTIVA	efavirenz	REMEDYREPACK INC.	NDA	Current
70518-0482	SUSTIVA	efavirenz	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76552	SUPPL	2023-11-13
76544	SUPPL	2023-11-09
60730	SUPPL	2019-10-30
60712	SUPPL	2019-10-30
50030	SUPPL	2017-10-12
50004	SUPPL	2017-10-11
47053	SUPPL	2017-01-31
47060	SUPPL	2017-01-30
45624	SUPPL	2016-10-17
45212	SUPPL	2016-08-31
45193	SUPPL	2016-08-31
36759	SUPPL	2016-04-01
5172	SUPPL	2016-04-01
15299	SUPPL	2015-04-02
5171	SUPPL	2015-04-01
36758	SUPPL	2014-05-28
27594	SUPPL	2014-05-27
5170	SUPPL	2013-05-07
15298	SUPPL	2013-05-03
27593	SUPPL	2012-08-15
15297	SUPPL	2012-08-15
15296	SUPPL	2012-06-26
5169	SUPPL	2012-06-26
5168	SUPPL	2011-12-21
36757	SUPPL	2011-12-19
5167	SUPPL	2011-09-29
36756	SUPPL	2011-09-27
5166	SUPPL	2010-12-03
15295	SUPPL	2010-11-29
5165	SUPPL	2010-04-05
15294	SUPPL	2010-04-04
27592	SUPPL	2009-11-10
15293	SUPPL	2009-10-01
15292	SUPPL	2009-04-23
5164	SUPPL	2009-03-12
36755	SUPPL	2008-08-26
27591	SUPPL	2008-08-20
42118	SUPPL	2007-07-20
21618	SUPPL	2007-07-20
27590	SUPPL	2007-02-05
15291	SUPPL	2007-02-05
36754	SUPPL	2007-02-02
5163	SUPPL	2007-02-02
36753	SUPPL	2005-04-28
5162	SUPPL	2005-04-28
15290	SUPPL	2004-11-01
27589	SUPPL	2004-10-29
27588	SUPPL	2004-08-25
15289	SUPPL	2004-08-25
36752	SUPPL	2003-12-01
27587	SUPPL	2003-11-26
27586	SUPPL	2003-06-22
27585	SUPPL	2003-06-22
15288	SUPPL	2003-06-22
15287	SUPPL	2003-06-22
5161	SUPPL	2002-09-20
21617	ORIG	2002-05-15
36751	ORIG	2002-02-01
27584	ORIG	2002-02-01