Treats obsessions and compulsions. NDA 19906, held by Specgx LLC. Clomipramine Hydrochloride.
As of Nov 13, 2026, NDA 19906 (Anafranil), held by Specgx LLC, was first approved by FDA on Dec 29, 1989, with 35 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Anafranil (clomipramine hydrochloride) Capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 1989 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Anafranil25MG · capsule;oral | Clomipramine Hydrochloride | RxReference drug |
| Anafranil50MG · capsule;oral | Clomipramine Hydrochloride | RxReference drug |
| Anafranil75MG · capsule;oral | Clomipramine Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2019 | Supplement 43Labeling | Approved | |
| Aug 22, 2018 | Supplement 41Labeling · Standard review | Approved | |
| May 24, 2017 | Supplement 40Labeling · Standard review | Approved | |
| Jul 28, 2014 | Supplement 39Labeling · Standard review | Approved | |
| Jul 10, 2014 | Supplement 38Labeling | Approved | |
| Oct 26, 2012 | Supplement 37Labeling · Standard review | Approved | |
| Jul 13, 2007 | Supplement 34Labeling · Standard review | Approved | |
| Jan 12, 2005 | Supplement 32Labeling · Standard review | Approved | |
| Sep 3, 2004 | Supplement 30Labeling · Standard review | Approved | |
| Jun 20, 2002 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jul 31, 2001 | Supplement 9Labeling | Approved | |
| Mar 23, 2001 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Oct 31, 2000 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Jul 3, 2000 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Apr 15, 1999 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Mar 8, 1999 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Jan 4, 1999 | Supplement 22Labeling · Standard review | Approved | |
| May 18, 1998 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jan 15, 1998 | Supplement 20Labeling · Standard review | Approved | None posted |
| Apr 2, 1997 | Supplement 19Labeling · Standard review | Approved | None posted |
| Apr 2, 1997 | Supplement 17Labeling · Standard review | Approved | None posted |
| Feb 11, 1997 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Dec 14, 1995 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1995 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Oct 20, 1995 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Oct 5, 1995 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1994 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Jul 1, 1994 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1994 | Supplement 12Labeling | Approved | None posted |
| Apr 13, 1994 | Supplement 8Labeling | Approved | None posted |
| May 15, 1991 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Apr 9, 1991 | Supplement 7Labeling | Approved | None posted |
| Apr 9, 1991 | Supplement 5Labeling | Approved | None posted |
| Apr 9, 1991 | Supplement 1Labeling | Approved | None posted |
| Jan 31, 1991 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Dec 29, 1989 | Original applicationNew molecular entity · Priority 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
