Application 020972

Type: NDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUSTIVA	EFAVIRENZ	CAPSULE;ORAL	50MG	Yes	No
002	SUSTIVA	EFAVIRENZ	CAPSULE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	SUSTIVA	EFAVIRENZ	CAPSULE;ORAL	200MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020972-001	SUSTIVA	EFAVIRENZ	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17
N020972-002	SUSTIVA	EFAVIRENZ	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17
N020972-003	SUSTIVA	EFAVIRENZ	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020972-002	SUSTIVA	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020972-003	SUSTIVA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020972-001	SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1998-09-17	`1e350fbaab3a…`

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	N020972-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020972-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020972-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020972-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020972-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020972-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020972-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020972-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020972-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020972-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020972-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020972-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020972-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020972-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020972-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020972-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020972-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020972-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020972-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020972-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020972-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020972-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020972-003	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020972-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020972-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020972-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020972-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020972-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020972-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020972-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020972-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020972-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020972-003	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020972-001	6238695	2019-04-06		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-001	6555133	2019-04-06	U-248		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-001	6238695*PED	2019-10-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-001	6555133*PED	2019-10-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-002	6238695	2019-04-06		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-002	6555133	2019-04-06	U-248		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-002	6238695*PED	2019-10-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-002	6555133*PED	2019-10-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-003	6238695	2019-04-06		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-003	6555133	2019-04-06	U-248		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-003	6238695*PED	2019-10-06		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020972-003	6555133*PED	2019-10-06		Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020972-001	6238695	2019-04-06		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-001	6555133	2019-04-06	U-248		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-001	6238695*PED	2019-10-06		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-001	6555133*PED	2019-10-06		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-002	6238695	2019-04-06		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-002	6555133	2019-04-06	U-248		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-002	6238695*PED	2019-10-06		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-002	6555133*PED	2019-10-06		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-003	6238695	2019-04-06		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-003	6555133	2019-04-06	U-248		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-003	6238695*PED	2019-10-06		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020972-003	6555133*PED	2019-10-06		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020972-001	6238695	2019-04-06		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-001	6555133	2019-04-06	U-248		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-001	6238695*PED	2019-10-06		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-001	6555133*PED	2019-10-06		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-002	6238695	2019-04-06		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-002	6555133	2019-04-06	U-248		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-002	6238695*PED	2019-10-06		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-002	6555133*PED	2019-10-06		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-003	6238695	2019-04-06		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-003	6555133	2019-04-06	U-248		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-003	6238695*PED	2019-10-06		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020972-003	6555133*PED	2019-10-06		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020972-001	6238695	2019-04-06		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020972-001	6555133	2019-04-06	U-248		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020972-001	6238695*PED	2019-10-06		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020972-001	6555133*PED	2019-10-06		Pediatric extension	`ea99ee380514…`

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0056-0470	SUSTIVA	Efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0470	SUSTIVA	Efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0470	SUSTIVA	Efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0470	SUSTIVA	Efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0470	SUSTIVA	Efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0470	SUSTIVA	Efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0474	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0474	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0474	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0474	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0474	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current
0056-0474	SUSTIVA	efavirenz	Bristol-Myers Squibb Pharma Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76553	SUPPL	2023-11-13
76545	SUPPL	2023-11-09
60729	SUPPL	2019-10-30
60713	SUPPL	2019-10-30
50029	SUPPL	2017-10-12
50005	SUPPL	2017-10-11
47054	SUPPL	2017-01-31
47061	SUPPL	2017-01-30
45623	SUPPL	2016-10-17
45211	SUPPL	2016-08-31
45194	SUPPL	2016-08-31
35745	SUPPL	2016-04-01
26326	SUPPL	2016-04-01
35744	SUPPL	2015-04-02
26325	SUPPL	2015-04-01
35743	SUPPL	2014-05-28
26324	SUPPL	2014-05-27
35742	SUPPL	2013-05-21
3880	SUPPL	2013-05-07
35741	SUPPL	2012-08-15
26323	SUPPL	2012-08-15
14044	SUPPL	2012-06-26
3879	SUPPL	2012-06-26
3878	SUPPL	2011-12-21
35740	SUPPL	2011-12-19
26322	SUPPL	2011-09-29
14043	SUPPL	2011-09-26
51697	SUPPL	2011-07-18
3877	SUPPL	2010-12-03
35739	SUPPL	2010-11-29
26321	SUPPL	2010-04-05
14042	SUPPL	2010-04-04
51694	SUPPL	2009-12-23
26320	SUPPL	2009-11-10
35738	SUPPL	2009-10-01
14041	SUPPL	2009-04-23
26319	SUPPL	2009-03-12
35737	SUPPL	2008-08-26
26318	SUPPL	2008-08-20
51692	SUPPL	2008-01-31
21314	SUPPL	2007-07-20
41849	SUPPL	2007-07-18
41848	SUPPL	2007-07-18
14040	SUPPL	2007-02-05
35736	SUPPL	2007-02-02
3876	SUPPL	2007-02-02
3875	SUPPL	2006-04-05
26317	SUPPL	2005-04-28
14039	SUPPL	2005-04-28
51670	SUPPL	2005-02-28
14038	SUPPL	2004-11-01
3874	SUPPL	2004-10-29
26316	SUPPL	2004-08-25
14037	SUPPL	2004-08-25
26313	SUPPL	2004-06-18
21313	SUPPL	2004-03-10
14036	SUPPL	2003-12-01
26315	SUPPL	2003-11-26
51667	SUPPL	2003-07-02
26314	SUPPL	2003-06-22
14035	SUPPL	2003-06-22
14034	SUPPL	2003-06-22
3873	SUPPL	2003-06-22
14033	SUPPL	2003-04-25
35735	SUPPL	2003-01-29
3871	SUPPL	2003-01-29
3872	SUPPL	2002-09-20
3870	SUPPL	2002-03-01
51662	SUPPL	2001-08-08
35734	SUPPL	2000-02-09
51657	SUPPL	1999-09-17
35733	ORIG	1998-09-17
26312	ORIG	1998-09-17
21312	ORIG	1998-09-17
51648	SUPPL	1996-09-17
52447	SUPPL	1900-01-01
52446	SUPPL	1900-01-01