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Generated: March 19, 2019

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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 two 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. Two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019715
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 0037-6860-10 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)
DIPENTUM olsalazine sodium CAPSULE;ORAL 019715 NDA Carilion Materials Management 68151-0312 68151-0312-1 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (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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