Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022057
Company: FERRING

Products on NDA 22057

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENDOMETRIN	PROGESTERONE	100MG	INSERT;VAGINAL	Prescription	AB	Yes	Yes

Labels for NDA 022057

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2026	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022057s012lbl.pdf
02/26/2008	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022057s001lbl.pdf
06/21/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022057lbl.pdf