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Last Updated: October 20, 2021

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Details for New Drug Application (NDA): 204412


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NDA 204412 describes DELZICOL, which is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. Additional details are available on the DELZICOL profile page.

The generic ingredient in DELZICOL is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 204412
Tradename:DELZICOL
Applicant:Apil
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204412
Medical Subject Heading (MeSH) Categories for 204412
Suppliers and Packaging for NDA: 204412
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412 NDA Allergan, Inc. 0023-5853 0023-5853-18 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0023-5853-18)
DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412 NDA A-S Medication Solutions 50090-3002 50090-3002-0 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3002-0)
Paragraph IV (Patent) Challenges for 204412
Tradename Dosage Ingredient NDA Submissiondate
DELZICOL CAPSULE, DELAYED RELEASE;ORAL mesalamine 204412 2014-06-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength400MG
Approval Date:Feb 1, 2013TE:ABRLD:Yes

Expired US Patents for NDA 204412

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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