Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016798
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SINEQUAN DOXEPIN HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SINEQUAN DOXEPIN HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SINEQUAN DOXEPIN HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SINEQUAN DOXEPIN HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SINEQUAN DOXEPIN HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SINEQUAN DOXEPIN HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
09/23/1969 ORIG-1 Approval Type 1 - New Molecular Entity 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
07/14/2014 SUPPL-56 Labeling-Medication Guide, 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-54 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-53 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-50 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-48 Labeling

Label is not available on this site.

03/27/2000 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/04/1990 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/27/1988 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1988 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1987 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1985 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/13/1984 SUPPL-34 Labeling

Label is not available on this site.

12/11/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/10/1984 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/01/1984 SUPPL-31 Labeling

Label is not available on this site.

09/26/1983 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/26/1983 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/22/1983 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1981 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1980 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/17/1979 SUPPL-25 Labeling

Label is not available on this site.

07/07/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1978 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/06/1978 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/12/1977 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/15/1978 SUPPL-20 Labeling

Label is not available on this site.

03/15/1978 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/28/1976 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1976 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1975 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1975 SUPPL-11 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/14/2014 SUPPL-56 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf
07/14/2014 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf
08/02/2007 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf

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