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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017516
Company: PFIZER

Other Important Information from FDA

Products on NDA 017516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SINEQUAN	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/1974	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017516_OriginalApprovalPackage.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2014	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016798Orig1s056,017516Orig1s025ltr.pdf
08/02/2007	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf
02/18/2005	SUPPL-22	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16798s053,17516s022ltr.pdf
09/30/2003	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17516slr020,16798slr050ltr.pdf
04/10/2000	SUPPL-18	Labeling		Label is not available on this site.
07/21/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/04/1989	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/22/1988	SUPPL-11	Labeling		Label is not available on this site.
09/13/1984	SUPPL-10	Labeling		Label is not available on this site.
05/01/1984	SUPPL-9	Labeling		Label is not available on this site.
11/30/1981	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/08/1978	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/30/1976	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/31/1975	SUPPL-3	Unspecified		Label is not available on this site.
09/23/1974	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 017516

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2014	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf
08/02/2007	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf

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