Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216569
Company: SCIEGEN PHARMS

Products on ANDA 216569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216569

CLOTRIMAZOLE

SOLUTION;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	209815	NOVITIUM PHARMA
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	216569	SCIEGEN PHARMS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	074580	SUN PHARMA CANADA
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	073306	TEVA
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	212281	TP ANDA HOLDINGS