Home Applications 203045 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 43 .
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 · 86 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 2026-09-14 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…2019-12-13 00:20 UTC 2019-12 N203045-001 ISENTRESS EQ 25MG BASE TABLET, CHEWABLE / ORAL RLD 2011-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203045-002 ISENTRESS EQ 100MG BASE TABLET, CHEWABLE / ORAL RLD, RS 2011-12-21 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 13 · 483 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203045-001 7754731*PED 2029-09-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203045-002 7754731*PED 2029-09-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203045-001 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203045-002 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203045-001 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203045-002 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203045-001 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203045-002 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203045-001 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203045-002 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203045-001 7754731*PED 2029-09-11 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203045-002 7754731*PED 2029-09-11 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203045-001 7754731 2029-03-11 U-257 Drug substance, Drug product 2012-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203045-001 7754731*PED 2029-09-11 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203045-002 7754731 2029-03-11 U-257 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203045-002 7754731*PED 2029-09-11 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203045-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 b8a1b40f171c…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…
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.
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