NDA 17111, held by Chartwell Rx. Molindone Hydrochloride.
As of Nov 13, 2026, NDA 17111 (Moban), held by Chartwell Rx, was first approved by FDA on Jan 18, 1974, with 36 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 1974 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Moban5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Moban100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Molindone Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2025 | Supplement 69Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 68Labeling | Approved | |
| Dec 1, 2010 | Supplement 67Labeling | Approved | |
| Jul 19, 2009 | Supplement 66Labeling | Approved | |
| Aug 14, 2008 | Supplement 63Labeling · Standard review | Approved | |
| Mar 12, 2008 | Supplement 62Labeling · Standard review | Approved | |
| May 22, 2001 | Supplement 55Labeling · Standard review | Approved | |
| Aug 21, 1998 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1998 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1996 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1995 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1995 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1995 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1994 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1988 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1988 | Supplement 45Labeling | Approved | None posted |
| Jun 28, 1988 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1987 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1986 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1985 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1982 | Supplement 33Labeling | Approved | None posted |
| Mar 24, 1981 | Supplement 30Labeling | Approved | None posted |
| Jan 6, 1981 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1981 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Dec 20, 1979 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1979 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 16, 1979 | Supplement 28Labeling | Approved | None posted |
| May 10, 1979 | Supplement 26Labeling | Approved | None posted |
| Jun 7, 1977 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 27, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Mar 14, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1977 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1977 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 20, 1976 | Supplement 7Labeling | Approved | None posted |
| Aug 26, 1976 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1974 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1974 | 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
