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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040564

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NDA 040564 describes DOXYLAMINE SUCCINATE, which is a drug marketed by Copley Pharm, LNK, Perrigo, Quantum Pharmics, Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, and Ph Health, and is included in nine NDAs. It is available from thirty-two suppliers. Additional details are available on the DOXYLAMINE SUCCINATE profile page.

The generic ingredient in DOXYLAMINE SUCCINATE is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

Summary for 040564

Tradename:	DOXYLAMINE SUCCINATE
Applicant:	Lnk
Ingredient:	doxylamine succinate
Patents:	0

Pharmacology for NDA: 040564

Mechanism of Action	Histamine Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 040564

Antiemetics
Histamine H1 Antagonists

Suppliers and Packaging for NDA: 040564

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	040564	ANDA	Walgreen Company	0363-0386	0363-0386-12	1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC
DOXYLAMINE SUCCINATE	doxylamine succinate	TABLET;ORAL	040564	ANDA	Walgreen Company	0363-0386	0363-0386-22	3 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Aug 27, 2004	TE:		RLD:	No

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