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PENTASA Drug Profile

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Pentasa is a drug marketed by Shire and is included in one NDA. It is available from six suppliers.

The generic ingredient in PENTASA is mesalamine. There are twenty-five drug master file entries for this compound. Eighteen 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 Tradename: PENTASA

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: PENTASA

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: PENTASA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXNo<disabled><disabled>
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-002Jul 8, 2004RXYes<disabled><disabled>
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Expired Patents for Tradename: PENTASA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,496,553<disabled>
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,980,173<disabled>
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