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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 five suppliers. Additional details are available on the PENTASA profile page.

The generic ingredient in PENTASA is mesalamine. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 020049

Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020049

Ingredient-typeAminosalicylic Acids

Suppliers and Packaging for NDA: 020049

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE, EXTENDED RELEASE;ORAL 020049 NDA Shire US Manufacturing Inc. 54092-189 54092-189-81 240 CAPSULE in 1 BOTTLE (54092-189-81)
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

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020049

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,496,553► subscribe
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,980,173► subscribe
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