Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021830

ASACOL HD (MESALAMINE)
800MG Marketing Status: Prescription

Active Ingredient: MESALAMINE
Proprietary Name: ASACOL HD
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 800MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021830
Product Number: 001
Approval Date: May 29, 2008
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
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