Application 203045

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, CHEWABLE;ORAL	EQ 25MG BASE	Yes	No
002	ISENTRESS	RALTEGRAVIR POTASSIUM	TABLET, CHEWABLE;ORAL	EQ 100MG 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
N203045-001	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 25MG BASE	TABLET, CHEWABLE / ORAL		RLD	2011-12-21
N203045-002	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 100MG BASE	TABLET, CHEWABLE / ORAL		RLD, RS	2011-12-21

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
N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20
N203045-001	7754731*PED	2029-09-11		Pediatric extension
N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product
N203045-002	7754731*PED	2029-09-11		Pediatric extension
N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203045-001	ISENTRESS	EQ 25MG BASE	TABLET, CHEWABLE / ORAL	RLD	2011-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203045-002	ISENTRESS	EQ 100MG BASE	TABLET, CHEWABLE / ORAL	RLD, RS	2011-12-21	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 2 of 13 · 488 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-002	7754731*PED	2029-09-11		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203045-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-001	7169780*PED	2024-04-03		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-001	7754731	2029-03-11	U-257	Drug substance, Drug product	2012-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-001	7754731*PED	2029-09-11		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-002	7169780*PED	2024-04-03		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203045-002	7754731	2029-03-11	U-257	Drug substance, Drug product		`79d66fd596c7…`

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	N203045-001	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-001	PED	2021-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-002	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203045-002	PED	2021-05-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N203045-001	PED	2021-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203045-002	PED	2021-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203045-001	PED	2021-05-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203045-002	PED	2021-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203045-001	PED	2021-05-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203045-002	PED	2021-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203045-001	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203045-001	PED	2021-05-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203045-002	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203045-002	PED	2021-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203045-001	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203045-001	PED	2021-05-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203045-002	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203045-002	PED	2021-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203045-001	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203045-001	PED	2021-05-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203045-002	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203045-002	PED	2021-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203045-001	NPP	2020-11-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203045-001	PED	2021-05-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203045-002	NPP	2020-11-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203045-002	PED	2021-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203045-001	NPP	2020-11-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203045-001	PED	2021-05-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203045-002	NPP	2020-11-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203045-002	PED	2021-05-22	`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
ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	89a5ec53-d956-4329-8004-0f40f51c88a3	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203045 application number: NDA203045 ndc (product): 0006-0473 ndc (product): 0006-0477

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0473	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0473	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0473	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-0473	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-0473	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0473	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0477	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0477	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0477	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-0477	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme LLC	NDA	Current
0006-0477	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current
0006-0477	ISENTRESS	RALTEGRAVIR	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67558	SUPPL	2021-05-20
67554	SUPPL	2021-05-19
63956	SUPPL	2020-07-17
63941	SUPPL	2020-07-16
52912	SUPPL	2018-03-12
52828	SUPPL	2018-03-06
50504	SUPPL	2017-12-06
50475	SUPPL	2017-11-24
48598	SUPPL	2017-05-31
48578	SUPPL	2017-05-31
32360	SUPPL	2015-02-24
40253	SUPPL	2015-02-23
40252	SUPPL	2015-02-20
10150	SUPPL	2015-02-19
40251	SUPPL	2014-04-10
32359	SUPPL	2014-04-10
32358	SUPPL	2013-12-31
40250	SUPPL	2013-12-23
32357	SUPPL	2013-10-25
19413	SUPPL	2013-10-25
32356	SUPPL	2013-08-06
19412	SUPPL	2013-08-06
40249	SUPPL	2013-07-03
10148	SUPPL	2013-07-02
19411	SUPPL	2013-04-09
10149	SUPPL	2013-04-09
40248	SUPPL	2012-08-15
32355	SUPPL	2012-08-15
44874	ORIG	2012-04-30
22906	ORIG	2012-04-30
32354	SUPPL	2012-04-23
19410	SUPPL	2012-04-20
32353	SUPPL	2012-04-02
19409	SUPPL	2012-03-28
32352	ORIG	2011-12-27
19408	ORIG	2011-12-23