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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020714
Company: PFIZER

Products on NDA 020714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICOTROL	NICOTINE	4MG/CARTRIDGE	INHALANT;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020714

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.

Labels for NDA 020714

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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