NDA 16798, held by Pfizer. Doxepin Hydrochloride.
As of Nov 13, 2026, NDA 16798 (Sinequan), held by Pfizer, was first approved by FDA on Sep 23, 1969, with 35 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 1969 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| SinequanEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Doxepin Hydrochloride | DiscontinuedReference drug |
| SinequanEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Doxepin Hydrochloride | DiscontinuedReference drug |
| SinequanEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Doxepin Hydrochloride | DiscontinuedReference drug |
| SinequanEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Doxepin Hydrochloride | DiscontinuedReference drug |
| SinequanEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Doxepin Hydrochloride | DiscontinuedReference drug |
| SinequanEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Doxepin Hydrochloride | DiscontinuedReference drug |
| Jul 3, 2025 | Supplement 57Labeling · Standard review | Approved | |
| Jul 14, 2014 | Supplement 56Labeling | Approved | |
| Aug 2, 2007 | Supplement 54Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 53Labeling · Standard review | Approved | |
| Sep 30, 2003 | Supplement 50Labeling · Standard review | Approved | |
| Apr 10, 2000 | Supplement 48Labeling · Standard review | Approved | None posted |
| Mar 27, 2000 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1994 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1990 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1988 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1988 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Sep 1, 1987 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1985 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1984 | Supplement 34Labeling | Approved | None posted |
| May 10, 1984 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| May 1, 1984 | Supplement 31Labeling | Approved | None posted |
| Sep 26, 1983 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1983 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jul 22, 1983 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1981 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1980 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1979 | Supplement 25Labeling | Approved | None posted |
| Jul 12, 1978 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jul 7, 1978 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 20Labeling | Approved | None posted |
| Mar 15, 1978 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1977 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1976 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jun 4, 1976 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1976 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1975 | Supplement 11Labeling | Approved | None posted |
| Apr 7, 1975 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1975 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1969 | Original applicationNew molecular entity · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
