Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020714
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICOTROL NICOTINE 4MG/CARTRIDGE INHALANT;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/02/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020714_nicotrol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2019 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020714s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020714Orig1s018ltr.pdf
06/17/2009 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020714s016ltr.pdf
07/16/2004 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20385s007,20714s012ltr.pdf
11/06/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20385slr006,20714slr011ltr.pdf
09/08/2002 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20714slr010ltr.pdf
11/16/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/2001 SUPPL-7 Labeling

Label is not available on this site.

11/02/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1999 SUPPL-5 Labeling

Label is not available on this site.

11/18/1998 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1999 SUPPL-3 Labeling

Label is not available on this site.

10/29/1997 SUPPL-2 Labeling

Label is not available on this site.

09/24/1997 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
08/29/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020714s018lbl.pdf

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