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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
US Army
Queensland Health
Express Scripts
Farmers Insurance
Cantor Fitzgerald

Generated: April 22, 2018

DrugPatentWatch Database Preview

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 two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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. Sixteen suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 204412
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204412
Ingredient-typeAminosalicylic Acids
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 N 0023-5853-18
DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412 NDA Allergan, Inc. 0023-5853 N 0023-5853-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength400MG
Approval Date:Feb 1, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 13, 2020Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Farmers Insurance

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