Application 021937

Type: NDA
Sponsor: GILEAD SCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATRIPLA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	600MG;200MG;300MG	Yes	Yes

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

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
N021937-001	ATRIPLA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-07-12

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021937-001	9018192	2026-06-13	U-1170		2015-05-28
N021937-001	9018192	2026-06-13	U-750		2015-05-28
N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13
N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13
N021937-001	8598185	2029-04-28		Drug product

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 · 44 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
2022-10-28 04:53 UTC	2022-10	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021937-001	ATRIPLA	600MG;200MG;300MG	TABLET / ORAL	AB	RLD, RS	2006-07-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021937-001	ATRIPLA	600MG;200MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-07-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021937-001	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021937-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021937-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021937-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021937-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021937-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021937-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021937-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021937-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021937-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021937-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021937-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021937-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021937-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021937-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021937-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021937-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021937-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021937-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021937-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021937-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021937-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021937-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021937-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021937-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021937-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021937-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021937-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021937-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021937-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021937-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 434 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	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021937-001	8598185	2029-04-28		Drug product		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021937-001	8598185	2029-04-28		Drug product		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021937-001	8598185	2029-04-28		Drug product		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021937-001	8598185	2029-04-28		Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021937-001	8598185	2029-04-28		Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021937-001	8598185	2029-04-28		Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021937-001	8598185	2029-04-28		Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9018192	2026-06-13	U-750		2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9018192	2026-06-13	U-1170		2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9545414	2026-06-13	U-1170	Drug product	2017-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	9545414	2026-06-13	U-750	Drug product	2017-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021937-001	8598185	2029-04-28		Drug product		`b8a1b40f171c…`

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
15584-0101	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	Gilead Sciences, LLC	NDA	Current
15584-0101	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	Gilead Sciences, LLC	NDA	Current
15584-0101	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	Gilead Sciences, LLC	NDA	Current
15584-0101	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	Gilead Sciences, LLC	NDA	Current
15584-0101	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	Gilead Sciences, LLC	NDA	Current
50090-0980	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	A-S Medication Solutions	NDA	Current
53808-0208	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	DOH CENTRAL PHARMACY	NDA	Current
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0341	Atripla	efavirenz, emtricitabine, and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60722	SUPPL	2019-10-30
60720	SUPPL	2019-10-30
55036	SUPPL	2018-07-30
55031	SUPPL	2018-07-27
47979	SUPPL	2017-04-12
47916	SUPPL	2017-04-10
37916	SUPPL	2016-02-18
6498	SUPPL	2016-02-12
37915	SUPPL	2015-12-03
6497	SUPPL	2015-11-23
37914	SUPPL	2015-01-29
6496	SUPPL	2015-01-26
16606	SUPPL	2013-10-25
6495	SUPPL	2013-10-25
28884	SUPPL	2013-04-23
37913	SUPPL	2013-04-19
16605	SUPPL	2012-06-18
6494	SUPPL	2012-06-18
37912	SUPPL	2011-09-20
6493	SUPPL	2011-09-20
6492	SUPPL	2010-08-11
16604	SUPPL	2010-08-10
6491	SUPPL	2010-01-15
37911	SUPPL	2010-01-08
28883	SUPPL	2008-10-23
37910	SUPPL	2008-06-12
28882	SUPPL	2008-06-09
37909	SUPPL	2008-03-05
28881	SUPPL	2008-03-04
37908	SUPPL	2008-02-25
28880	SUPPL	2008-02-20
21875	ORIG	2006-12-13
28879	ORIG	2006-07-21
16603	ORIG	2006-07-12