Details for New Drug Application (NDA): 208085

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NDA 208085 describes XTRELUS, which is a drug marketed by Eci Pharms Llc and is included in one NDA. Additional details are available on the XTRELUS profile page.

The generic ingredient in XTRELUS is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.

Summary for 208085

Tradename:	XTRELUS
Applicant:	Eci Pharms Llc
Ingredient:	guaifenesin; hydrocodone bitartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG;5MG
Approval Date:	Apr 25, 2018	TE:		RLD:	Yes

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