Application 207561

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENVOYA	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	150MG;150MG;200MG;EQ 10MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N207561-001	GENVOYA	COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL		RLD, RS	2015-11-05

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207561-001	7176220	2026-08-27	U-257	Drug substance, Drug product	2015-12-01
N207561-001	7635704	2026-10-26	U-257	Drug substance, Drug product	2015-12-01
N207561-001	8981103	2026-10-26		Drug substance, Drug product	2015-12-01
N207561-001	7176220*PED	2027-02-27		Pediatric extension
N207561-001	7635704*PED	2027-04-26		Pediatric extension
N207561-001	8981103*PED	2027-04-26		Pediatric extension
N207561-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-12-01
N207561-001	9891239	2029-09-03	U-257	Drug product	2018-02-27
N207561-001	8148374*PED	2030-03-03		Pediatric extension
N207561-001	9891239*PED	2030-03-03		Pediatric extension
N207561-001	8633219	2030-04-30	U-257	Drug product	2015-12-01
N207561-001	8633219*PED	2030-10-30		Pediatric extension
N207561-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2015-12-01
N207561-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-22
N207561-001	10039718	2032-10-06		Drug product	2018-08-28
N207561-001	8754065*PED	2033-02-15		Pediatric extension
N207561-001	9296769*PED	2033-02-15		Pediatric extension
N207561-001	10039718*PED	2033-04-06		Pediatric extension

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207561-001	GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2015-11-05	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 787 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207561-001	7176220	2026-08-27	U-257	Drug substance, Drug product	2015-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	7635704	2026-10-26	U-257	Drug substance, Drug product	2015-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8981103	2026-10-26		Drug substance, Drug product	2015-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	7176220*PED	2027-02-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	7635704*PED	2027-04-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8981103*PED	2027-04-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	9891239	2029-09-03	U-257	Drug product	2018-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8148374*PED	2030-03-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	9891239*PED	2030-03-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8633219	2030-04-30	U-257	Drug product	2015-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8633219*PED	2030-10-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2015-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	10039718	2032-10-06		Drug product	2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207561-001	10039718*PED	2033-04-06		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	7390791	2025-01-07		Drug substance, Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	7176220	2026-08-27	U-257	Drug substance, Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	7635704	2026-10-26	U-257	Drug substance, Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8981103	2026-10-26		Drug substance, Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	7176220*PED	2027-02-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	7635704*PED	2027-04-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8981103*PED	2027-04-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8148374	2029-09-03	U-1279	Drug substance, Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	9891239	2029-09-03	U-257	Drug product	2018-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8148374*PED	2030-03-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	9891239*PED	2030-03-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8633219	2030-04-30	U-257	Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8633219*PED	2030-10-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2015-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	10039718	2032-10-06		Drug product	2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207561-001	10039718*PED	2033-04-06		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207561-001	7390791	2025-01-07		Drug substance, Drug product	2015-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207561-001	7390791*PED	2025-07-07		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207561-001	NPP	2020-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207561-001	NCE	2020-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207561-001	D-173	2021-12-10	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N207561-001	D-173	2021-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207561-001	D-173	2021-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207561-001	D-173	2021-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207561-001	NPP	2020-09-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207561-001	NCE	2020-11-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207561-001	D-173	2021-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207561-001	NPP	2020-09-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207561-001	NCE	2020-11-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207561-001	D-173	2021-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207561-001	NPP	2020-09-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207561-001	NCE	2020-11-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207561-001	D-173	2021-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207561-001	NPP	2020-09-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207561-001	NCE	2020-11-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207561-001	D-173	2021-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207561-001	NPP	2020-09-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207561-001	NCE	2020-11-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207561-001	D-173	2021-12-10	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Genvoya	ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE	Gilead Sciences, Inc.	34784acf-15ed-4715-b504-eb30430518e9	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207561 application number: NDA207561 ndc (product): 61958-1901

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
50090-2279	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	A-S Medication Solutions	NDA	Current
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-1901	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
70518-0568	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	REMEDYREPACK INC.	NDA	Current
70518-0568	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	REMEDYREPACK INC.	NDA	Current
70518-0568	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	REMEDYREPACK INC.	NDA	Current
70518-0568	Genvoya	elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69831	SUPPL	2022-01-11
69826	SUPPL	2022-01-11
68623	SUPPL	2021-09-15
68596	SUPPL	2021-09-13
66608	SUPPL	2021-03-08
66546	SUPPL	2021-03-05
65589	SUPPL	2020-12-15
65490	SUPPL	2020-12-03
58041	SUPPL	2019-03-19
58039	SUPPL	2019-03-19
56837	SUPPL	2018-12-20
56717	SUPPL	2018-12-12
56472	SUPPL	2018-11-15
56282	SUPPL	2018-11-06
55094	SUPPL	2018-08-03
55072	SUPPL	2018-08-02
50508	SUPPL	2017-11-27
50477	SUPPL	2017-11-24
49877	SUPPL	2017-09-28
49860	SUPPL	2017-09-26
49488	SUPPL	2017-08-21
49455	SUPPL	2017-08-17
47984	SUPPL	2017-04-12
47909	SUPPL	2017-04-10
47255	SUPPL	2017-02-16
47254	SUPPL	2017-02-16
46100	SUPPL	2016-12-08
46093	SUPPL	2016-12-08
45280	SUPPL	2016-09-19
45312	SUPPL	2016-09-15
45248	SUPPL	2016-09-09
45242	SUPPL	2016-09-08
40589	SUPPL	2016-03-14
32856	SUPPL	2016-03-10
44960	ORIG	2015-12-08
23037	ORIG	2015-12-08
19964	ORIG	2015-11-12
32855	ORIG	2015-11-09
54153	SUPPL	1900-01-01
52454	SUPPL	1900-01-01
52453	ORIG	1900-01-01
52452	ORIG	1900-01-01
52451	ORIG	1900-01-01