Details for New Drug Application (NDA): 020049

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NDA 020049 describes PENTASA, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the PENTASA profile page.

The generic ingredient in PENTASA 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 020049

Tradename:	PENTASA
Applicant:	Takeda Pharms Usa
Ingredient:	mesalamine
Patents:	0

Pharmacology for NDA: 020049

Medical Subject Heading (MeSH) Categories for 020049

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 020049

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049	NDA	Takeda Pharmaceuticals America, Inc.	54092-189	54092-189-81	240 CAPSULE in 1 BOTTLE (54092-189-81)
PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049	NDA	Takeda Pharmaceuticals America, Inc.	54092-191	54092-191-12	120 CAPSULE in 1 BOTTLE (54092-191-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	250MG
Approval Date:	May 10, 1993	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Jul 8, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020049

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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