Details for New Drug Application (NDA): 065221

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NDA 065221 describes RIFAMPIN AND ISONIAZID, which is a drug marketed by Hikma Intl Pharms and is included in one NDA. Additional details are available on the RIFAMPIN AND ISONIAZID profile page.

The generic ingredient in RIFAMPIN AND ISONIAZID is isoniazid; rifampin. There are five drug master file entries for this compound. Additional details are available on the isoniazid; rifampin profile page.

Summary for 065221

Tradename:	RIFAMPIN AND ISONIAZID
Applicant:	Hikma Intl Pharms
Ingredient:	isoniazid; rifampin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	150MG;300MG
Approval Date:	Jul 29, 2005	TE:		RLD:	No

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