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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211783
Company: XIROMED

Products on ANDA 211783

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	No	No
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	No	No
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211783

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211783orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211783

ESTRADIOL

GEL;TRANSDERMAL; 0.1% (0.25GM/PACKET)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIVIGEL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	Yes	AB	022038	VERTICAL PHARMS
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	216055	AMNEAL
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	218507	ENCUBE
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	217610	NOVITIUM PHARMA
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	216524	PADAGIS ISRAEL
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	217863	SOLARIS PHARMA CORP
ESTRADIOL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	211783	XIROMED

GEL;TRANSDERMAL; 0.1% (0.5GM/PACKET)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIVIGEL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	Yes	AB	022038	VERTICAL PHARMS
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	216055	AMNEAL
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	218507	ENCUBE
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	217610	NOVITIUM PHARMA
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	216524	PADAGIS ISRAEL
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	217863	SOLARIS PHARMA CORP
ESTRADIOL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	211783	XIROMED

GEL;TRANSDERMAL; 0.1% (1GM/PACKET)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIVIGEL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	Yes	AB	022038	VERTICAL PHARMS
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	216055	AMNEAL
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	218507	ENCUBE
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	217610	NOVITIUM PHARMA
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	216524	PADAGIS ISRAEL
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	217863	SOLARIS PHARMA CORP
ESTRADIOL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	No	AB	211783	XIROMED

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