Details for New Drug Application (NDA): 204412

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NDA 204412 describes DELZICOL, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. 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-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 204412

Tradename:	DELZICOL
Applicant:	Abbvie
Ingredient:	mesalamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 204412

Anti-Inflammatory Agents, Non-Steroidal

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 AUTHORIZED GENERIC	Greenstone LLC	59762-0117	59762-0117-1	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	400MG
Approval Date:	Feb 1, 2013	TE:		RLD:	Yes

Expired US Patents for NDA 204412

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	5,541,170	⤷ Get Started Free
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	6,649,180	⤷ Get Started Free
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	5,541,171	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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