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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 four suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASACOL HD profile page.

The generic ingredient in ASACOL HD is mesalamine. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 021830

Tradename:
ASACOL HD
Applicant:
Apil
Ingredient:
mesalamine
Patents:3
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021830

Ingredient-typeAminosalicylic Acids

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)
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL 021830 NDA Warner Chilcott (US), LLC 0430-0783 0430-0783-00 273572 TABLET, DELAYED RELEASE in 1 DRUM (0430-0783-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength800MG
Approval Date:May 29, 2008TE:RLD:Yes
Patent:8,580,302Patent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:9,089,492Patent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:6,893,662Patent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ULCERATIVE COLITIS

Expired Orange Book 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;ORAL021830-001May 29, 20085,541,170► subscribe
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 20085,541,171► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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