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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017516
Company: PFIZER

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SINEQUAN DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CONCENTRATE;ORAL Discontinued None Yes No

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
07/03/2025 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016798s057,017516s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/016798Orig1s057,017516Orig1s026ltr.pdf
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/03/2025 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016798s057,017516s026lbl.pdf
07/03/2025 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016798s057,017516s026lbl.pdf
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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