Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012427
Company: PFIZER

Products on NDA 12427

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIDREX	BENZPHETAMINE HYDROCHLORIDE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
DIDREX	BENZPHETAMINE HYDROCHLORIDE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 012427

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2020	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012427s031lbl.pdf
02/05/2010	SUPPL-26	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf