Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202985
Company: ZYDUS PHARMS

Products on ANDA 202985

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202985

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2023	ORIG-1	Approval				Label is not available on this site.