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Generated: April 21, 2019

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Details for New Drug Application (NDA): 020049

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NDA 020049 describes PENTASA, which is a drug marketed by Shire and is included in one NDA. It is available from three suppliers. 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. Twenty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 020049
Tradename:PENTASA
Applicant:Shire
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020049
Medical Subject Heading (MeSH) Categories for 020049
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 Shire US Manufacturing Inc. 54092-189 54092-189-81 240 CAPSULE in 1 BOTTLE (54092-189-81)
PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049 NDA Shire US Manufacturing Inc. 54092-191 54092-191-08 1 BLISTER PACK in 1 CARTON (54092-191-08) > 8 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength250MG
Approval Date:May 10, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 8, 2004TE:RLD:Yes

Expired US Patents for NDA 020049

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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