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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 050678

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NDA 050678 describes DYNABAC, which is a drug marketed by Lilly Res Labs and is included in one NDA. Additional details are available on the DYNABAC profile page.

The generic ingredient in DYNABAC is dirithromycin. There are two drug master file entries for this compound. Additional details are available on the dirithromycin profile page.

Summary for 050678

Tradename:	DYNABAC
Applicant:	Lilly Res Labs
Ingredient:	dirithromycin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	250MG
Approval Date:	Jun 19, 1995	TE:		RLD:	No

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