NDA 17407, held by Boehringer Ingelheim. Clonidine Hydrochloride.
As of Nov 13, 2026, NDA 17407 (Catapres), held by Boehringer Ingelheim, was first approved by FDA on Sep 3, 1974, with 35 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 1979 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Sep 3, 1974 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Catapres0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Catapres0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Catapres0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2015 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| May 31, 2012 | Supplement 37Labeling | Approved | |
| Apr 7, 2010 | Supplement 36Labeling | Approved | |
| Jan 5, 2010 | Supplement 33Labeling · Standard review | Approved | |
| Nov 9, 2009 | Supplement 34Labeling · Standard review | Approved | |
| Apr 13, 1999 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 30, 1998 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Nov 3, 1997 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Aug 2, 1996 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 2, 1996 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jun 20, 1988 | Supplement 26Labeling | Approved | None posted |
| Sep 8, 1987 | Supplement 19Labeling | Approved | None posted |
| Sep 2, 1987 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Mar 26, 1987 | Supplement 25Labeling | Approved | None posted |
| Apr 11, 1986 | Supplement 23Labeling | Approved | None posted |
| Oct 2, 1985 | Supplement 22Labeling | Approved | None posted |
| Mar 6, 1985 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1984 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Nov 3, 1982 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Aug 5, 1981 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1981 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Feb 20, 1981 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Feb 20, 1981 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Feb 5, 1981 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Dec 10, 1980 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Sep 16, 1980 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Sep 12, 1980 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1980 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Sep 20, 1979 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Nov 27, 1978 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jan 17, 1977 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Dec 10, 1976 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Oct 27, 1976 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jul 26, 1976 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1976 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1974 | Original applicationNew dosage form · 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
