Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214137
Company: TEVA PHARMS USA INC

Products on ANDA 214137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	AB	No	No
ESTRADIOL	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214137Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214137

ESTRADIOL

INSERT;VAGINAL; 0.004MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	No	AB	214137	TEVA PHARMS USA INC
IMVEXXY	ESTRADIOL	0.004MG	INSERT;VAGINAL	Prescription	Yes	AB	208564	MAYNE PHARMA

INSERT;VAGINAL; 0.01MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	No	AB	214137	TEVA PHARMS USA INC
IMVEXXY	ESTRADIOL	0.01MG	INSERT;VAGINAL	Prescription	Yes	AB	208564	MAYNE PHARMA