Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204379
Company: ZYDUS PHARMS

Products on ANDA 204379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.014MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204379Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 204379

ESTRADIOL

SYSTEM;TRANSDERMAL; 0.014MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.014MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	204379	ZYDUS PHARMS
MENOSTAR	ESTRADIOL	0.014MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB	021674	BAYER HLTHCARE