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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019715


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NDA 019715 describes DIPENTUM, which is a drug marketed by Mylan Spclt Viatris and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the olsalazine sodium profile page.
Summary for 019715
Tradename:DIPENTUM
Applicant:Mylan Spclt Viatris
Ingredient:olsalazine sodium
Patents:0
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 Inc. 0037-6860 0037-6860-10 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)

Profile for product number 001

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

Expired US Patents for NDA 019715

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Spclt Viatris DIPENTUM olsalazine sodium CAPSULE;ORAL 019715-001 Jul 31, 1990 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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