Home Applications 021997 Application 021997
Type NDA
Sponsor MYLAN SPECIALITY LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EDLUAR ZOLPIDEM TARTRATE TABLET;SUBLINGUAL 5MG Yes No 002 EDLUAR ZOLPIDEM TARTRATE TABLET;SUBLINGUAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021997-001 EDLUAR ZOLPIDEM TARTRATE 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 N021997-002 EDLUAR ZOLPIDEM TARTRATE 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021997-001 9597281 2027-04-06 U-674 2017-04-07 N021997-001 9265720 2031-02-25 U-674 2016-03-18 N021997-002 9597281 2027-04-06 U-674 2017-04-07 N021997-002 9265720 2031-02-25 U-674 2016-03-18
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021997-001 EDLUAR 5MG TABLET / SUBLINGUAL AB RLD 2009-03-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021997-002 EDLUAR 10MG TABLET / SUBLINGUAL AB RLD, RS 2009-03-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 180 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021997-001 9597281 2027-04-06 U-674 2017-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-001 9265720 2031-02-25 U-674 2016-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-002 9597281 2027-04-06 U-674 2017-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021997-002 9265720 2031-02-25 U-674 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-001 9597281 2027-04-06 U-674 2017-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-001 9265720 2031-02-25 U-674 2016-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-002 9597281 2027-04-06 U-674 2017-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021997-002 9265720 2031-02-25 U-674 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021997-001 9597281 2027-04-06 U-674 2017-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-001 9265720 2031-02-25 U-674 2016-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-002 9597281 2027-04-06 U-674 2017-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021997-002 9265720 2031-02-25 U-674 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-001 9597281 2027-04-06 U-674 2017-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-001 9265720 2031-02-25 U-674 2016-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-002 9597281 2027-04-06 U-674 2017-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021997-002 9265720 2031-02-25 U-674 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-001 9597281 2027-04-06 U-674 2017-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-001 9265720 2031-02-25 U-674 2016-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-002 9597281 2027-04-06 U-674 2017-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021997-002 9265720 2031-02-25 U-674 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-001 9597281 2027-04-06 U-674 2017-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-001 9265720 2031-02-25 U-674 2016-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-002 9597281 2027-04-06 U-674 2017-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021997-002 9265720 2031-02-25 U-674 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-001 9597281 2027-04-06 U-674 2017-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-001 9265720 2031-02-25 U-674 2016-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-002 9597281 2027-04-06 U-674 2017-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021997-002 9265720 2031-02-25 U-674 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-001 9597281 2027-04-06 U-674 2017-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-001 9265720 2031-02-25 U-674 2016-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-002 9597281 2027-04-06 U-674 2017-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021997-002 9265720 2031-02-25 U-674 2016-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-001 9597281 2027-04-06 U-674 2017-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-001 9265720 2031-02-25 U-674 2016-03-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-002 9597281 2027-04-06 U-674 2017-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021997-002 9265720 2031-02-25 U-674 2016-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021997-001 9597281 2027-04-06 U-674 2017-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021997-001 9265720 2031-02-25 U-674 2016-03-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021997-002 9597281 2027-04-06 U-674 2017-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021997-002 9265720 2031-02-25 U-674 2016-03-18 d06236e962d9…
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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6010 Edluar Zolpidem Tartrate Meda Pharmaceuticals NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals Inc. NDA Current 0037-6050 Edluar Zolpidem Tartrate Meda Pharmaceuticals NDA Current