Home Applications 040564 Application 040564
Type ANDA
Sponsor LNK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE TABLET;ORAL 25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A040564-001 DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27
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 2 · 41 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 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040564-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 2004-08-27 cb3db0bc1861…
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 2 · 24 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 112 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 11822-0386 Sleep Aid Doxylamine succinate Rite Aid Corporation ANDA Current 11822-0386 Sleep Aid Doxylamine succinate Rite Aid Corporation ANDA Current 11822-9386 sleep aid doxylamine succinate Rite Aid Corporation ANDA Current 11822-9386 sleep aid doxylamine succinate Rite Aid Corporation ANDA Current 11822-9386 sleep aid doxylamine succinate Rite Aid Corporation ANDA Current 11822-9386 sleep aid doxylamine succinate Rite Aid Corporation ANDA Current 11822-9386 sleep aid doxylamine succinate Rite Aid Corporation ANDA Current 11822-9386 sleep aid doxylamine succinate Rite Aid Corporation ANDA Current 21130-386 Nighttime Sleep Aid Doxylamine succinate Better Living Brands, LLC ANDA Current 21130-386 Nighttime Sleep Aid Doxylamine succinate Better Living Brands, LLC ANDA Current 21130-986 Nighttime Sleep Aid Doxylamine Succinate Better Living Brands, LLC ANDA Current 21130-986 Nighttime Sleep Aid Doxylamine Succinate Better Living Brands, LLC ANDA Current 21130-986 Nighttime Sleep Aid Doxylamine Succinate Better Living Brands, LLC ANDA Current 21130-986 Nighttime Sleep Aid Doxylamine Succinate Better Living Brands, LLC ANDA Current 21130-986 Nighttime Sleep Aid Doxylamine Succinate Better Living Brands, LLC ANDA Current 27854-375 Nocto Sleep Aid Doxylamine succinate Belmora LLC ANDA Current 27854-375 Nocto Sleep Aid Doxylamine succinate Belmora LLC ANDA Current 27854-375 Nocto Sleep Aid Doxylamine succinate Belmora LLC ANDA Current 27854-375 Nocto Sleep Aid Doxylamine succinate Belmora LLC ANDA Current 30142-386 Sleep Aid Doxylamine succinate Kroger Company ANDA Current 30142-386 Sleep Aid Doxylamine succinate Kroger Company ANDA Current 37205-671 Sleep Aid Doxylamine succinate CARDINAL HEALTH ANDA Current 37808-386 Sleep-Aid Doxylamine succinate H E B ANDA Current 37808-886 Nighttime Sleep Aid Doxylamine Succinate H E B ANDA Current 37808-886 Nighttime Sleep Aid Doxylamine Succinate H E B ANDA Current 37808-886 Nighttime Sleep Aid Doxylamine Succinate H E B ANDA Current 37808-886 Nighttime Sleep Aid Doxylamine Succinate H E B ANDA Current 37808-986 Nighttime Sleep-Aid Doxylamine succinate H E B ANDA Current 37808-986 Nighttime Sleep-Aid Doxylamine succinate H E B ANDA Current 37808-986 Nighttime Sleep-Aid Doxylamine succinate H E B ANDA Current 41163-386 Sleep Aid Doxylamine succinate SUPERVALU INC. ANDA Current 41163-386 Sleep Aid Doxylamine succinate SUPERVALU INC. ANDA Current 41163-986 Sleep Aid Doxylamine Succinate SUPERVALU INC. ANDA Current 41163-986 Sleep Aid Doxylamine Succinate SUPERVALU INC. ANDA Current 41163-986 Sleep Aid Doxylamine Succinate SUPERVALU INC. ANDA Current 41163-986 Sleep Aid Doxylamine Succinate SUPERVALU INC. ANDA Current 41250-986 Sleep Aid Doxylamine Succinate Meijer Distribution Inc ANDA Current 41250-986 Sleep Aid Doxylamine Succinate Meijer Distribution Inc ANDA Current 41250-986 Sleep Aid Doxylamine Succinate Meijer Distribution Inc ANDA Current 41250-986 Sleep Aid Doxylamine Succinate Meijer Distribution Inc ANDA Current 41250-986 Sleep Aid Doxylamine Succinate Meijer Distribution Inc ANDA Current 49035-863 Nighttime Sleep Aid Doxylamine succinate Wal-Mart Stores Inc ANDA Current 49035-863 Nighttime Sleep Aid Doxylamine succinate Wal-Mart Stores Inc ANDA Current 49035-968 Sleep Aid Doxylamine Succinate Wal-Mart Stores Inc ANDA Current 49035-968 Sleep Aid Doxylamine Succinate Wal-Mart Stores Inc ANDA Current 49035-968 Sleep Aid Doxylamine Succinate Wal-Mart Stores Inc ANDA Current 49035-968 Sleep Aid Doxylamine Succinate Wal-Mart Stores Inc ANDA Current 49035-968 Sleep Aid Doxylamine Succinate Wal-Mart Stores Inc ANDA Current 49035-968 Sleep Aid Doxylamine Succinate Wal-Mart Stores Inc ANDA Current 50844-260 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-260 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-260 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-260 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-260 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-386 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-386 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-386 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-386 Nighttime Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 50844-952 Sleep Aid Doxylamine succinate L.N.K. International, Inc. ANDA Current 55301-386 Sleep Aid Doxylamine succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-386 Sleep Aid Doxylamine succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-986 Sleep Aid Doxylamine Succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-986 Sleep Aid Doxylamine Succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-986 Sleep Aid Doxylamine Succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-986 Sleep Aid Doxylamine Succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55301-986 Sleep Aid Doxylamine Succinate ARMY AND AIR FORCE EXCHANGE SERVICE ANDA Current 55315-886 Sleep Aid Doxylamine Succinate FRED'S, INC. ANDA Current 55315-886 Sleep Aid Doxylamine Succinate FRED'S, INC. ANDA Current 55315-886 Sleep Aid Doxylamine Succinate FRED'S, INC. ANDA Current 55315-986 Sleep Aid Doxylamine succinate FRED'S, INC. ANDA Current 55315-986 Sleep Aid Doxylamine succinate FRED'S, INC. ANDA Current 55315-986 Sleep Aid Doxylamine succinate FRED'S, INC. ANDA Current 59779-863 Nighttime Sleep Aid Doxylamine succinate CVS Pharmacy ANDA Current 59779-863 Nighttime Sleep Aid Doxylamine succinate CVS Pharmacy ANDA Current 62011-0344 sleep aid doxylamine succinate McKesson (Health Mart) ANDA Current 62011-0401 Sleep Aid Doxylamine Succinate Strategic Sourcing Services, LLC (Health Mart) ANDA Current 62011-0401 Sleep Aid Doxylamine Succinate Strategic Sourcing Services, LLC (Health Mart) ANDA Current 62011-0401 Sleep Aid Doxylamine Succinate Strategic Sourcing Services, LLC (Health Mart) ANDA Current 62011-0401 Sleep Aid Doxylamine Succinate McKesson (Health Mart) ANDA Current 62011-0401 Sleep Aid Doxylamine Succinate Strategic Sourcing Services, LLC (Health Mart) ANDA Current