ANDA 70288, held by Actavis Mid Atlantic. Lactulose.
As of Nov 13, 2026, ANDA 70288 (Constulose), held by Actavis Mid Atlantic, was first approved by FDA on Aug 15, 1988, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Constulose10GM/15ML ยท solution;oral | Lactulose | Discontinued |
| Dec 16, 1997 | Supplement 24Manufacturing | Approved | None posted |
| Aug 26, 1996 | Supplement 23Manufacturing | Approved | None posted |
| Jan 17, 1996 | Supplement 22Manufacturing | Approved | None posted |
| Sep 9, 1994 | Supplement 21Manufacturing | Approved | None posted |
| Aug 3, 1993 | Supplement 19Manufacturing | Approved | None posted |
| Jun 4, 1993 | Supplement 18Manufacturing | Approved | None posted |
| Jun 4, 1993 | Supplement 20Manufacturing | Approved | None posted |
| Feb 11, 1993 | Supplement 16Manufacturing | Approved | None posted |
| Jan 27, 1992 | Supplement 13Manufacturing | Approved | None posted |
| Aug 21, 1991 | Supplement 9Labeling | Approved | None posted |
| Aug 21, 1991 | Supplement 42Labeling | Approved | None posted |
| Jul 24, 1991 | Supplement 17Manufacturing | Approved | None posted |
| Feb 21, 1991 | Supplement 15Labeling | Approved | None posted |
| Sep 28, 1990 | Supplement 14Manufacturing | Approved | None posted |
| Jul 31, 1990 | Supplement 12Labeling | Approved | None posted |
| Aug 19, 1988 | Supplement 1Labeling | Approved | None posted |
| Aug 15, 1988 | Original application | 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
