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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`caaa826d4ba7…`
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…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Night Time Sleep Aid	DOXYLAMINE SUCCINATE	Advanced Rx LLC	db8b730a-1553-4682-96bf-41e670ed0347	2025-02-26	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Family Dollar Stores, Inc	d91f0c21-28f0-4d32-a1d2-fae406b90bf7	2023-07-25	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Allegiant Health	3761182c-275b-40f3-a262-9ef5f5a80723	2023-03-16	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564

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 2 of 2 · 112 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63981-386	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-386	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
64092-350	Nighttime Sleep Aid	Doxylamine succinate	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-350	Nighttime Sleep Aid	Doxylamine succinate	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-350	Nighttime Sleep Aid	Doxylamine succinate	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS Pharmacy	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS Pharmacy	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
70000-0249	Sleep Aid	Doxylamine succinate	Cardinal Health	ANDA	Current
70000-0249	Sleep Aid	Doxylamine succinate	Cardinal Health	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health	ANDA	Current
70677-0025	Sleep Aid	Doxylamine succinate	McKesson (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	McKesson (Sunmark)	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current