Details for New Drug Application (NDA): 021876

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NDA 021876 describes DICLEGIS, which is a drug marketed by Duchesnay and is included in one NDA. It is available from two suppliers. Additional details are available on the DICLEGIS profile page.

The generic ingredient in DICLEGIS 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 021876

Tradename:	DICLEGIS
Applicant:	Duchesnay
Ingredient:	doxylamine succinate; pyridoxine hydrochloride
Patents:	0

Pharmacology for NDA: 021876

Ingredient-type	Analogs/Derivatives Vitamin B 6
Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 021876

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100	55494-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)
DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100	55494-100-99	12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	10MG;10MG
Approval Date:	Apr 8, 2013	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021876

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	⤷ Sign Up	⤷ Sign Up
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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