Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218941
Company: AUROBINDO PHARMA LTD

Products on ANDA 218941

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218941

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218941

METRONIDAZOLE

GEL;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METROGEL	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	Yes	AB	021789	GALDERMA LABS LP
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	212646	ALEMBIC
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	218941	AUROBINDO PHARMA LTD
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	216692	COSETTE PHARMS NC
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	204651	TARO