An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019983
Company: AVEVA

Products on NDA 19983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROSTEP	NICOTINE	11MG/24HR	Film, Extended Release; Transdermal	Discontinued	None	No	No
PROSTEP	NICOTINE	22MG/24HR	Film, Extended Release; Transdermal	Discontinued	None	No	No
PROSTEP	NICOTINE	11MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No
PROSTEP	NICOTINE	22MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued	None	No	No

Labels for NDA 019983

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2002	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf

Top