NDA 50475, held by Bausch. Griseofulvin, Ultramicrosize.
As of Nov 13, 2026, NDA 50475 (Gris-Peg), held by Bausch, was first approved by FDA on Apr 16, 1975, with 46 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gris-Peg125MG · tablet;oral | Griseofulvin, Ultramicrosize | RxReference drug |
| Gris-Peg250MG · tablet;oral | Griseofulvin, Ultramicrosize | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2016 | Supplement 59Manufacturing | Approved | |
| Apr 19, 2016 | Supplement 57Labeling · Standard review | Approved | |
| May 8, 2013 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Oct 19, 2010 | Supplement 54Labeling · Standard review | Approved | |
| Jan 24, 2007 | Supplement 53Labeling · Standard review | Approved | |
| Mar 26, 2003 | Supplement 46Labeling · Standard review | Approved | |
| Aug 1, 2002 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jun 3, 2002 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Jul 2, 2001 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Dec 6, 2000 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1998 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1997 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1988 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1986 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1985 | Supplement 5Labeling | Approved | None posted |
| Oct 24, 1984 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1984 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1983 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 26, 1983 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1982 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1982 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1982 | Supplement 42Labeling | Approved | None posted |
| Feb 5, 1982 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1981 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Mar 5, 1981 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1980 | Supplement 31Labeling | Approved | None posted |
| Nov 21, 1980 | Supplement 24Labeling | Approved | None posted |
| Aug 13, 1980 | Supplement 32Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1980 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1980 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Apr 10, 1979 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1977 | Supplement 21Labeling | Approved | None posted |
| Apr 20, 1977 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1976 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 18, 1976 | Supplement 18Labeling | Approved | None posted |
| Nov 18, 1976 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Oct 1, 1976 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1976 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1976 | Supplement 15Labeling | Approved | None posted |
| Apr 1, 1976 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1976 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1975 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1975 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1975 | 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
