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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019715

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NDA 019715 describes DIPENTUM, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from three suppliers. Additional details are available on the DIPENTUM profile page.

The generic ingredient in DIPENTUM is olsalazine sodium. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the olsalazine sodium profile page.
Summary for 019715
Applicant:Mylan Speciality Lp
Ingredient:olsalazine sodium
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019715
Ingredient-typeAminosalicylic Acids
Suppliers and Packaging for NDA: 019715
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPENTUM olsalazine sodium CAPSULE;ORAL 019715 NDA MEDA Pharmaceuticals 0037-6860 N 0037-6860-10
DIPENTUM olsalazine sodium CAPSULE;ORAL 019715 NDA Carilion Materials Management 68151-0312 N 68151-0312-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jul 31, 1990TE:RLD:Yes

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