FDA.reportPublic FDA data

Application 206510

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUTREBISLAMIVUDINE; RALTEGRAVIR POTASSIUMTABLET;ORAL150MG;EQ 300MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206510-001DUTREBISLAMIVUDINE; RALTEGRAVIR POTASSIUM150MG;EQ 300MG BASETABLET / ORAL2015-02-06

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04
N206510-0017754731*PED2029-09-11Pediatric 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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N206510-001DUTREBIS150MG;EQ 300MG BASETABLET / ORAL2015-02-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206510-001DUTREBIS150MG;EQ 300MG BASETABLET / ORAL2015-02-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206510-001DUTREBIS150MG;EQ 300MG BASETABLET / ORAL2015-02-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206510-001DUTREBIS150MG;EQ 300MG BASETABLET / ORAL2015-02-06a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 7 · 255 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04c2088c7a36db…
2026-10-15 13:18:302026-09N206510-0017754731*PED2029-09-11Pediatric extensionc2088c7a36db…
2026-09-14 22:38:342026-08N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-0484e616aacf4f…
2026-09-14 22:38:342026-08N206510-0017754731*PED2029-09-11Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07N206510-0017754731*PED2029-09-11Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206510-0017754731*PED2029-09-11Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206510-0017754731*PED2029-09-11Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206510-0017754731*PED2029-09-11Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206510-0017754731*PED2029-09-11Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206510-0017754731*PED2029-09-11Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206510-0017169780*PED2024-04-03Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206510-0017754731*PED2029-09-11Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206510-0017169780*PED2024-04-03Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206510-0017754731*PED2029-09-11Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206510-0017169780*PED2024-04-03Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206510-0017754731*PED2029-09-11Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206510-0017169780*PED2024-04-03Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206510-0017754731*PED2029-09-11Pediatric extensiond8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206510-0017169780*PED2024-04-03Pediatric extensiond06236e962d9…
2024-10-29 15:01 UTC2024-10N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N206510-0017754731*PED2029-09-11Pediatric extensiond06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206510-0017169780*PED2024-04-03Pediatric extension79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206510-0017754731*PED2029-09-11Pediatric extension79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206510-0017169780*PED2024-04-03Pediatric extension301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206510-0017754731*PED2029-09-11Pediatric extension301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206510-0017169780*PED2024-04-03Pediatric extension1e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206510-00177547312029-03-11U-1663Drug substance, Drug product2015-03-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206510-0017754731*PED2029-09-11Pediatric extension1e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44946ORIG2016-04-11
23023ORIG2016-04-11
10576ORIG2015-02-12
40554ORIG2015-02-10
63111ORIG1900-01-01
63110ORIG1900-01-01