Details for New Drug Application (NDA): 021830

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NDA 021830 describes ASACOL HD, which is a drug marketed by Abbvie and is included in one NDA. Additional details are available on the ASACOL HD profile page.

The generic ingredient in ASACOL HD is mesalamine. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 021830

Tradename:	ASACOL HD
Applicant:	Abbvie
Ingredient:	mesalamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 021830

Anti-Inflammatory Agents, Non-Steroidal

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 29, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 021830

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	9,089,492	⤷ Subscribe
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,170	⤷ Subscribe
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	8,580,302	⤷ Subscribe
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	6,893,662	⤷ Subscribe
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,171	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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