Home Applications 209805 Application 209805
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 5MG;EQ 100MG BASE Yes No 002 STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE TABLET;ORAL 15MG;EQ 100MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N209805-001 STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 N209805-002 STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 N209805-001 7326708*PED 2027-05-24 Pediatric extension N209805-001 9308204 2030-10-21 Drug product 2018-01-16 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 N209805-001 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 N209805-002 7326708*PED 2027-05-24 Pediatric extension N209805-002 9308204 2030-10-21 Drug product 2018-01-16 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 N209805-002 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16
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 3 · 84 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 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 13 · 508 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 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 82 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme LLC NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme LLC NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5367 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme LLC NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme LLC NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current 0006-5368 STEGLUJAN ertugliflozin and sitagliptin Merck Sharp & Dohme Corp. NDA Current