Home Applications 210807 Application 210807
Type NDA
Sponsor MSD MERCK CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DELSTRIGO DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 100MG;300MG;300MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N210807-001 DELSTRIGO DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30
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 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 N210807-001 10842751 2036-11-29 Drug product 2020-12-16
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 · 43 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 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 5 · 193 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 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 67 observed states.
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 DELSTRIGO DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE Merck Sharp & Dohme LLC cd1e9f84-607a-46d3-b01e-2736018d67b6 2026-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210807 application number: NDA210807 ndc (product): 0006-5007
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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme Corp. NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme Corp. NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme LLC NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme LLC NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme Corp. NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme Corp. NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme Corp. NDA Current 0006-5007 DELSTRIGO doravirine, lamivudine, and tenofovir disoproxil fumarate Merck Sharp & Dohme Corp. NDA Current