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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216550
Company: AUROBINDO PHARMA

Products on ANDA 216550

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 216550

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216550

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

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