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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 Meda Pharms 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 NDA: 019715

Tradename:
DIPENTUM
Applicant:
Meda Pharms
Ingredient:
olsalazine sodium
Patents:0
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 0037-6860-10 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)
DIPENTUM
olsalazine sodium
CAPSULE;ORAL 019715 NDA Carilion Materials Management 68151-3120 68151-3120-1 1 CAPSULE, GELATIN COATED in 1 PACKAGE (68151-3120-1)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019715

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
DIPENTUM
olsalazine sodium
CAPSULE;ORAL019715-001Jul 31, 19904,559,330► subscribe
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