Details for New Drug Application (NDA): 022362

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NDA 022362 describes WELCHOL, which is a drug marketed by Cosette and is included in four NDAs. It is available from three suppliers. 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. Sixteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for 022362

Tradename:	WELCHOL
Applicant:	Cosette
Ingredient:	colesevelam hydrochloride
Patents:	0

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	Cosette Pharmaceuticals, Inc.	0713-0880	0713-0880-30	30 PACKET in 1 CARTON (0713-0880-30) / 1 FOR SUSPENSION in 1 PACKET
WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362	NDA	Cosette Pharmaceuticals, Inc.	0713-0935	0713-0935-30	30 PACKET in 1 CARTON (0713-0935-30) / 1 FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 2, 2009	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 20, 2024
Regulatory Exclusivity Use:	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

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
Regulatory Exclusivity Expiration:	Oct 20, 2024
Regulatory Exclusivity Use:	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Expired US Patents for NDA 022362

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	7,229,613*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	6,433,026*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	5,917,007*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	5,919,832*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	7,101,960*PED	⤷ Subscribe
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