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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019983
Company: AVEVA

Products on NDA 019983

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019983

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/1992	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2002	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983slr017ltr.pdf
01/18/2002	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983s16ltr.pdf
05/07/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
04/04/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
12/23/1998	SUPPL-12	Efficacy-Rx To OTC Switch	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm
12/23/1998	SUPPL-11	Manufacturing (CMC)	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm
01/26/1996	SUPPL-8	Labeling		Label is not available on this site.
02/02/1993	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/1993	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/01/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/13/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

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