Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215610
Company: ENCUBE

Products on ANDA 215610

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215610

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215610

METRONIDAZOLE

GEL;VAGINAL; 0.75%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METROGEL-VAGINAL	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	Yes	AB	020208	BAUSCH
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	216323	COSETTE
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	215610	ENCUBE
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	215794	GLENMARK PHARMS LTD
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	211786	PADAGIS ISRAEL
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	213648	SOLARIS PHARMA CORP