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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020385
Company: PFIZER INC

Products on NDA 020385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICOTROL	NICOTINE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/1996	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
08/29/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020385s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020385Orig1s011ltr.pdf
06/29/2010	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020385s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020385s010ltr.pdf
07/16/2004	SUPPL-7	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-6	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-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20385slr005ltr.pdf
07/09/2001	SUPPL-3	Labeling		Label is not available on this site.
08/14/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020385

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020385s011lbl.pdf
06/29/2010	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020385s010lbl.pdf

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