Home Applications 205786 Application 205786
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 POWDER;ORAL EQ 100MG BASE/PACKET Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N205786-001 ISENTRESS RALTEGRAVIR POTASSIUM EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 N205786-001 7754731*PED 2029-09-11 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 · 42 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 2026-08-18 06:07:40 2026-07 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205786-001 ISENTRESS EQ 100MG BASE/PACKET POWDER / ORAL RLD, RS 2013-12-20 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 6 · 227 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205786-001 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205786-001 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205786-001 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205786-001 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205786-001 7754731*PED 2029-09-11 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205786-001 7754731*PED 2029-09-11 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205786-001 7169780*PED 2024-04-03 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205786-001 7754731*PED 2029-09-11 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205786-001 7169780*PED 2024-04-03 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205786-001 7754731*PED 2029-09-11 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205786-001 7169780*PED 2024-04-03 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205786-001 7754731*PED 2029-09-11 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205786-001 7169780*PED 2024-04-03 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205786-001 7754731*PED 2029-09-11 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205786-001 7169780*PED 2024-04-03 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205786-001 7754731*PED 2029-09-11 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205786-001 7169780*PED 2024-04-03 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205786-001 7754731*PED 2029-09-11 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205786-001 7169780*PED 2024-04-03 Pediatric extension 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205786-001 7754731*PED 2029-09-11 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205786-001 7169780*PED 2024-04-03 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205786-001 7754731*PED 2029-09-11 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205786-001 7169780*PED 2024-04-03 Pediatric extension 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205786-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2014-01-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205786-001 7754731*PED 2029-09-11 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205786-001 7217713 2022-10-21 U-257 2014-01-16 5c6f7cd8ea54…
Observed Orange Book exclusivity history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3603 ISENTRESS RALTEGRAVIR Merck Sharp & Dohme Corp. NDA Current 0006-3603 ISENTRESS RALTEGRAVIR Merck Sharp & Dohme Corp. NDA Current 0006-3603 ISENTRESS RALTEGRAVIR Merck Sharp & Dohme LLC NDA Current 0006-3603 ISENTRESS RALTEGRAVIR Merck Sharp & Dohme LLC NDA Current 0006-3603 ISENTRESS RALTEGRAVIR Merck Sharp & Dohme Corp. NDA Current 0006-3603 ISENTRESS RALTEGRAVIR Merck Sharp & Dohme Corp. NDA Current