Details for New Drug Application (NDA): 021830

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NDA 021830 describes ASACOL HD, which is a drug marketed by Apil and is included in one NDA. It is available from one supplier. 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. Thirty-three suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 021830

Tradename:	ASACOL HD
Applicant:	Apil
Ingredient:	mesalamine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021830

Medical Subject Heading (MeSH) Categories for 021830

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 021830

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830	NDA	Allergan, Inc.	0023-5901	0023-5901-18	180 TABLET, DELAYED RELEASE in 1 BOTTLE (0023-5901-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	800MG
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
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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