NDA 11808, held by Novartis. Thioridazine Hydrochloride.
As of Nov 13, 2026, NDA 11808 (Mellaril), held by Novartis, was first approved by FDA on Mar 15, 1962, with 48 approved supplements and 0 published complete response letters.
| Dec 7, 2007 | Supplement 31Efficacy (new indication or use) | Approved | None posted |
| Mar 15, 1962 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Mellaril10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · concentrate;oral | Thioridazine Hydrochloride | Discontinued |
| Mellaril200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Thioridazine Hydrochloride | DiscontinuedReference drug |
| Mellaril100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · concentrate;oral | Thioridazine Hydrochloride | Discontinued |
| Dec 7, 2007 | Supplement 174Labeling · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 171Labeling · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 166Labeling · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 164Labeling · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 160Labeling · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 159Labeling · Standard review | Approved | None posted |
| Dec 7, 2007 | Supplement 157Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 154Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 153Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 152Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 150Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 148Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 145Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 139Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 137Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 136Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 129Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 128Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 126Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 118Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 107Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 106Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 105Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 101Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 97Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 96Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 93Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 85Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 77Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 68Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 61Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 59Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 31Efficacy (new indication or use) | Approved | None posted |
| Dec 7, 2007 | Supplement 29Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 28Labeling | Approved | None posted |
| Jun 15, 2001 | Supplement 177Manufacturing · Priority review | Approved | None posted |
| Mar 28, 2001 | Supplement 179Manufacturing · Priority review | Approved | None posted |
| Mar 15, 2001 | Supplement 178Labeling · Standard review | Approved | |
| Jun 19, 2000 | Supplement 175Labeling · Standard review | Approved | None posted |
| Mar 1, 2000 | Supplement 176Manufacturing · Priority review | Approved | None posted |
| May 25, 1999 | Supplement 172Manufacturing · Priority review | Approved | None posted |
| Apr 15, 1999 | Supplement 173Manufacturing · Priority review | Approved | None posted |
| Jan 15, 1997 | Supplement 170Manufacturing · Priority review | Approved | None posted |
| Mar 20, 1996 | Supplement 169Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1995 | Supplement 168Manufacturing · Priority review | Approved | None posted |
| Oct 17, 1995 | Supplement 165Manufacturing · Priority review | Approved | None posted |
| Dec 2, 1994 | Supplement 138Manufacturing · Priority review | Approved | None posted |
| Nov 28, 1994 | Supplement 117Manufacturing · Priority review | Approved | None posted |
| Mar 15, 1962 | 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
