Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216524
Company: PADAGIS ISRAEL

Products on ANDA 216524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216524

ESTRADIOL

GEL;TRANSDERMAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIVIGEL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	Yes	AB	022038	VERTICAL PHARMS
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	No	AB	211783	CHEMO RESEARCH SL
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	No	AB	217610	NOVITIUM PHARMA
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	No	AB	216524	PADAGIS ISRAEL