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 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. Forty 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

Pharmacology for NDA: 204412

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	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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	400MG
Approval Date:	Feb 1, 2013	TE:	AB	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	⤷ Sign Up	⤷ Sign Up
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	⤷ Sign Up	⤷ Sign Up
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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