NDA 18029, held by Novartis. Methylphenidate Hydrochloride.
As of Nov 13, 2026, NDA 18029 (Ritalin-Sr), held by Novartis, was first approved by FDA on Mar 30, 1982, with 45 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 1982 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ritalin-Sr20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Methylphenidate Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2019 | Supplement 59Labeling · Standard review | Approved | |
| Jan 10, 2019 | Supplement 41Labeling · Standard review | Approved | |
| Jan 10, 2019 | Supplement 51Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 55Labeling | Approved | |
| Dec 1, 2015 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2015 | Supplement 49Labeling | Approved | |
| Dec 13, 2013 | Supplement 47Labeling · Standard review | Approved | |
| Oct 25, 2013 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 7, 2013 | Supplement 44Labeling · Standard review | Approved | |
| Dec 9, 2010 | Supplement 43Labeling · Standard review | Approved | |
| Nov 15, 2010 | Supplement 42Labeling | Approved | |
| Apr 25, 2007 | Supplement 40Labeling · Standard review | Approved | |
| Aug 8, 2006 | Supplement 37Labeling · Standard review | Approved | |
| Aug 8, 2006 | Supplement 38Labeling · Standard review | Approved | |
| May 21, 2004 | Supplement 28Labeling · Standard review | Approved | |
| May 21, 2004 | Supplement 29Labeling · Standard review | Approved | |
| Jun 12, 2002 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| May 29, 2002 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 11, 2002 | Supplement 32Labeling · Standard review | Approved | |
| Aug 15, 2001 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2001 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1999 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1998 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1998 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1998 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1998 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1998 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jul 9, 1997 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jul 9, 1997 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jul 9, 1997 | Supplement 13Labeling | Approved | None posted |
| Jul 9, 1997 | Supplement 10Labeling | Approved | None posted |
| Dec 15, 1995 | Supplement 19Labeling · Standard review | Approved | None posted |
| Aug 19, 1994 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 31, 1994 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1994 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1994 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1993 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1990 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1988 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1988 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1987 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1986 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1986 | Supplement 6Labeling | Approved | None posted |
| Mar 13, 1985 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1983 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1982 | Original applicationNew formulation or manufacturer · 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
