Drug information for MONISTAT 1 COMBINATION PACK

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CREAM, SUPPOSITORY; TOPICAL, VAGINAL	2%,1.2GM	Over The Counter	(Reference Drug)	MICONAZOLE NITRATE	Miconazole	INSIGHT PHARMS	21308 2007-11-19 Review 2005-04-06 Letter 2004-10-05 Letter 2004-10-05 Label 2004-06-09 Letter 2004-06-09 Letter 2004-06-09 Letter 2004-06-09 Review 2003-12-08 Letter 2003-05-07 Label

Drug Adverse Effects information for MONISTAT 1 COMBINATION PACK

Role code	Indications	Reaction	# Reports
PS	FUNGAL INFECTION	CHILLS	2
PS	FUNGAL INFECTION	DRUG INEFFECTIVE	2
PS	FUNGAL INFECTION	HERPES VIRUS INFECTION	2
PS	FUNGAL INFECTION	VAGINAL DISORDER	2
PS	FUNGAL INFECTION	VAGINAL HAEMORRHAGE	2
PS	FUNGAL INFECTION	VULVOVAGINAL BURNING SENSATION	4
PS	FUNGAL INFECTION	VULVOVAGINAL ERYTHEMA	2
PS	FUNGAL INFECTION	VULVOVAGINAL PRURITUS	2
PS	FUNGAL INFECTION	VULVOVAGINAL SWELLING	2
PS	FUNGAL INFECTION	WRONG TECHNIQUE IN DRUG USAGE PROCESS	2
SS	FUNGAL INFECTION	CHILLS	6
SS	FUNGAL INFECTION	HERPES VIRUS INFECTION	6
SS	FUNGAL INFECTION	VAGINAL DISORDER	6
SS	FUNGAL INFECTION	VAGINAL HAEMORRHAGE	6
SS	FUNGAL INFECTION	VULVOVAGINAL BURNING SENSATION	6
SS	FUNGAL INFECTION	VULVOVAGINAL ERYTHEMA	6
SS	FUNGAL INFECTION	VULVOVAGINAL PRURITUS	6
SS	FUNGAL INFECTION	VULVOVAGINAL SWELLING	6
SS	FUNGAL INFECTION	WRONG TECHNIQUE IN DRUG USAGE PROCESS	6

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