Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019983
Company: AVEVA
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
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.

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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