Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204412

DELZICOL (MESALAMINE)
400MG Marketing Status: Prescription

Active Ingredient: MESALAMINE
Proprietary Name: DELZICOL
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204412
Product Number: 001
Approval Date: Feb 1, 2013
Applicant Holder Full Name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
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