Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019617
Company: PFIZER

Products on NDA 19617

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREPIDIL	DINOPROSTONE	0.5MG/3GM	GEL;ENDOCERVICAL	Prescription	None	Yes	Yes

Labels for NDA 019617

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/05/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019617s017lbl.pdf
02/12/2010	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019617s010lbl.pdf