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Last Updated: December 12, 2025

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	Viatris Specialty LLC	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:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jul 31, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019715

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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	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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