Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086069
Company: ALLERGAN

Products on ANDA 86069

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRACE	ESTRADIOL	0.01%	CREAM;VAGINAL	Prescription	AB	Yes	Yes

Labels for ANDA 086069

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2022	SUPPL-26	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/086069Orig1s026lbl.pdf
08/17/2005	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf