Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205256
Company: AMNEAL PHARMS

Products on ANDA 205256

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	10MCG	TABLET;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205256

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2025	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/04/2025	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/04/2025	SUPPL-10	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/17/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/17/2021	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 205256

ESTRADIOL

TABLET;VAGINAL; 10MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	10MCG	TABLET;VAGINAL	Prescription	No	AB	205256	AMNEAL PHARMS
ESTRADIOL	ESTRADIOL	10MCG	TABLET;VAGINAL	Prescription	No	AB	216550	AUROBINDO PHARMA
ESTRADIOL	ESTRADIOL	10MCG	TABLET;VAGINAL	Prescription	No	AB	210264	GLENMARK PHARMS LTD
ESTRADIOL	ESTRADIOL	10MCG	TABLET;VAGINAL	Prescription	No	AB	206388	TEVA PHARMS USA
VAGIFEM	ESTRADIOL	10MCG	TABLET;VAGINAL	Prescription	Yes	AB	020908	NOVO NORDISK INC