Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212313
Company: PRASCO

Products on ANDA 212313

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212313

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2021	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
05/19/2025	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
02/16/2024	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/08/2024	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212313

ESTRADIOL

CREAM;VAGINAL; 0.01%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRACE	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	Yes	AB	086069	ALLERGAN
ESTRADIOL	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	No	AB	209767	ENCUBE
ESTRADIOL	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	No	AB	208788	MYLAN
ESTRADIOL	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	No	AB	210194	PADAGIS ISRAEL
ESTRADIOL	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	No	AB	212313	PRASCO
ESTRADIOL	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	No	AB	210488	TEVA PHARMS USA