Application 022145

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISENTRESS	RALTEGRAVIR POTASSIUM	TABLET;ORAL	EQ 400MG BASE	Yes	Yes
002	ISENTRESS HD	RALTEGRAVIR POTASSIUM	TABLET;ORAL	EQ 600MG BASE	Yes	Yes

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

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
N022145-001	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12
N022145-002	ISENTRESS HD	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022145-001	AB
N022145-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27
N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product
N022145-001	7754731*PED	2029-09-11		Pediatric extension
N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27
N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23
N022145-002	7754731*PED	2029-09-11		Pediatric extension
N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27
N022145-002	9649311	2030-10-21		Drug product	2017-06-23
N022145-002	9649311*PED	2031-04-21		Pediatric extension
N022145-002	10772888	2032-03-30	U-1663		2020-10-27

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 · 88 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
2026-10-15 13:18:30	2026-09	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022145-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022145-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022145-002	AB	1	`6a471c1ec25d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-001	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022145-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 704 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	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022145-001	D-167	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	PED	2020-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	PED	2021-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	NS	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	PED	2020-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	PED	2021-05-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022145-001	PED	2021-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022145-002	PED	2021-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022145-001	PED	2021-05-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022145-002	PED	2021-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022145-001	PED	2021-05-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022145-002	PED	2021-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022145-001	D-167	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	PED	2020-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	PED	2021-05-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	NS	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	PED	2020-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	PED	2021-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022145-001	D-167	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	PED	2020-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	PED	2021-05-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	NS	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	PED	2020-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	PED	2021-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022145-001	D-167	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	PED	2020-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	PED	2021-05-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	NS	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	PED	2020-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	PED	2021-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022145-001	D-167	2020-05-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022145-001	NPP	2020-11-22	`b00525d2431f…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISENTRESS	RALTEGRAVIR	NuCare Pharmaceuticals,Inc.	46ef8e2e-ae63-6a3c-e054-00144ff8d46c	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022145 application number: NDA022145 ndc (product): 68071-2113
ISENTRESS	RALTEGRAVIR	Proficient Rx LP	ccc6f2f9-696f-4ef9-bb4c-e0198d957b0b	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022145 application number: NDA022145

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 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0227	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0227	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0227	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-0227	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-0227	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0227	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-3080	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-3080	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-3080	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-3080	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-3080	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-3080	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
50090-1085	ISENTRESS	RALTEGRAVIR	A-S Medication Solutions	NDA	Current
50090-1085	ISENTRESS	RALTEGRAVIR	A-S Medication Solutions	NDA	Current
50090-1085	ISENTRESS	RALTEGRAVIR	A-S Medication Solutions	NDA	Current
50090-1085	ISENTRESS	RALTEGRAVIR	A-S Medication Solutions	NDA	Current
50090-1085	ISENTRESS	RALTEGRAVIR	A-S Medication Solutions	NDA	Current
53808-0650	ISENTRESS	raltegravir	State of Florida DOH Central Pharmacy	NDA	Current
61919-706	ISENTRESS	ISENTRESS	DIRECT RX	NDA	Current
61919-706	ISENTRESS	ISENTRESS	Direct_Rx	NDA	Current
61919-706	ISENTRESS	ISENTRESS	Direct_Rx	NDA	Current
61919-706	ISENTRESS	ISENTRESS	Direct_Rx	NDA	Current
61919-706	ISENTRESS	ISENTRESS	DIRECT RX	NDA	Current
61919-706	ISENTRESS	ISENTRESS	DIRECT RX	NDA	Current
66336-214	ISENTRESS	RALTEGRAVIR	Dispensing Solutions, Inc.	NDA	Current
67296-1235	ISENTRESS	ISENTRESS	RedPharm Drug, Inc.	NDA	Current
67296-1235	ISENTRESS	ISENTRESS	RedPharm Drug, Inc.	NDA	Current
67296-1235	ISENTRESS	ISENTRESS	RedPharm Drug, Inc.	NDA	Current
68071-2113	ISENTRESS	RALTEGRAVIR	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2113	ISENTRESS	RALTEGRAVIR	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2113	ISENTRESS	RALTEGRAVIR	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2113	ISENTRESS	RALTEGRAVIR	NuCare Pharmaceuticals,Inc.	NDA	Current
70518-1621	ISENTRESS	RALTEGRAVIR	REMEDYREPACK INC.	NDA	Current
70518-1621	ISENTRESS	RALTEGRAVIR	REMEDYREPACK INC.	NDA	Current
70518-1621	ISENTRESS	RALTEGRAVIR	REMEDYREPACK INC.	NDA	Current
70518-1621	ISENTRESS	RALTEGRAVIR	REMEDYREPACK INC.	NDA	Current
76519-1130	ISENTRESS	RALTEGRAVIR	H.J. Harkins Company Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67557	SUPPL	2021-05-20
67553	SUPPL	2021-05-19
63957	SUPPL	2020-07-17
63940	SUPPL	2020-07-16
54629	SUPPL	2018-06-20
53012	SUPPL	2018-03-15
52826	SUPPL	2018-03-06
50505	SUPPL	2017-12-06
50474	SUPPL	2017-11-24
48599	SUPPL	2017-05-31
48579	SUPPL	2017-05-31
6964	SUPPL	2015-02-24
38308	SUPPL	2015-02-23
17014	SUPPL	2015-02-20
6963	SUPPL	2015-02-19
29320	SUPPL	2014-04-10
17013	SUPPL	2014-04-10
29319	SUPPL	2013-12-31
38307	SUPPL	2013-12-23
6962	SUPPL	2013-10-25
29318	SUPPL	2013-08-06
17012	SUPPL	2013-08-05
17011	SUPPL	2013-07-03
6961	SUPPL	2013-07-02
38306	SUPPL	2013-04-09
29317	SUPPL	2013-04-09
38305	SUPPL	2012-08-15
29316	SUPPL	2012-08-15
6960	SUPPL	2012-04-23
17010	SUPPL	2012-04-20
42429	SUPPL	2012-04-13
29315	SUPPL	2012-04-02
38303	SUPPL	2012-03-28
6959	SUPPL	2011-12-28
38304	SUPPL	2011-12-23
17009	SUPPL	2011-11-16
6958	SUPPL	2011-11-07
6955	SUPPL	2011-06-17
6957	SUPPL	2011-04-13
38302	SUPPL	2011-04-11
38301	SUPPL	2011-03-04
6956	SUPPL	2011-03-01
38300	SUPPL	2010-07-06
17006	SUPPL	2010-07-06
29313	SUPPL	2010-07-02
6953	SUPPL	2010-07-02
17008	SUPPL	2010-04-04
6954	SUPPL	2010-04-02
29314	SUPPL	2010-01-20
17007	SUPPL	2009-11-23
6951	SUPPL	2009-07-15
38299	SUPPL	2009-07-09
29310	SUPPL	2009-02-09
17004	SUPPL	2009-02-04
29311	SUPPL	2009-02-03
17005	SUPPL	2009-01-14
6952	SUPPL	2009-01-14
38298	SUPPL	2008-11-07
29312	SUPPL	2008-10-28
42428	ORIG	2008-02-22
24250	ORIG	2008-02-22
29309	ORIG	2007-10-22
17003	ORIG	2007-10-15
64064	ORIG	1900-01-01
64063	ORIG	1900-01-01
64062	ORIG	1900-01-01
64061	ORIG	1900-01-01
64060	ORIG	1900-01-01
63547	SUPPL	1900-01-01
63546	SUPPL	1900-01-01
52953	SUPPL	1900-01-01
51636	SUPPL	1900-01-01
51635	SUPPL	1900-01-01
51634	SUPPL	1900-01-01