Details for New Drug Application (NDA): 022362

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NDA 022362 describes WELCHOL, which is a drug marketed by Daiichi Sankyo and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the WELCHOL profile page.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for 022362

Tradename:	WELCHOL
Applicant:	Daiichi Sankyo
Ingredient:	colesevelam hydrochloride
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022362

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 022362

Anticholesteremic Agents

Suppliers and Packaging for NDA: 022362

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362	NDA	Rebel Distributors Corp	21695-779	21695-779-30	30 FOR SUSPENSION in 1 BOX (21695-779-30)
WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362	NDA	Ohm Laboratories, Inc.	51660-995	51660-995-30	30 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	1.875GM/PACKET
Approval Date:	Oct 2, 2009	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Oct 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	3.75GM/PACKET
Approval Date:	Oct 2, 2009	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Oct 17, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022362

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	➤ Sign Up	➤ Sign Up
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	➤ Sign Up	➤ Sign Up
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	➤ Sign Up	➤ Sign Up
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	➤ Sign Up	➤ Sign Up
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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