NDA 17657, held by Sanofi Aventis US. Lactulose.
As of Nov 13, 2026, NDA 17657 (Cephulac), held by Sanofi Aventis US, was first approved by FDA on Mar 25, 1976, with 29 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 1980 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 25, 1976 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cephulac10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral, rectal | Lactulose | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 1993 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1992 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 5, 1991 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Feb 22, 1990 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| May 16, 1989 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Dec 9, 1988 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Dec 7, 1988 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| May 27, 1988 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Sep 18, 1987 | Supplement 25Labeling · Priority review | Approved | None posted |
| Mar 9, 1987 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| May 31, 1984 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jan 14, 1983 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Oct 22, 1981 | Supplement 18Labeling · Priority review | Approved | None posted |
| Oct 22, 1981 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Nov 13, 1980 | Supplement 16Labeling · Priority review | Approved | None posted |
| Oct 3, 1980 | Supplement 15Labeling · Priority review | Approved | None posted |
| Aug 20, 1980 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 29, 1980 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jun 27, 1980 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jun 20, 1980 | Supplement 13Labeling · Priority review | Approved | None posted |
| Mar 4, 1980 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Dec 27, 1979 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| May 4, 1979 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Nov 21, 1978 | Supplement 8Labeling · Priority review | Approved | None posted |
| Dec 8, 1977 | Supplement 6Labeling · Priority review | Approved | None posted |
| Dec 8, 1977 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Nov 3, 1977 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| May 12, 1977 | Supplement 3Labeling · Priority review | Approved | None posted |
| May 12, 1977 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 25, 1976 | 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
