NDA 12699, held by Gd Searle LLC. Atropine Sulfate; Diphenoxylate Hydrochloride.
As of Nov 13, 2026, NDA 12699 (Lomotil), held by Gd Searle LLC, was first approved by FDA on Oct 19, 1961, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 1961 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lomotil0.025MG/5ML;2.5MG/5ML · solution;oral | Atropine Sulfate; Diphenoxylate Hydrochloride | Discontinued |
| Apr 28, 2006 | Supplement 36Labeling · Priority review | Approved | |
| Feb 18, 1994 | Supplement 35Labeling · Priority review | Approved | None posted |
| Apr 23, 1991 | Supplement 34Labeling · Priority review | Approved | None posted |
| Mar 12, 1987 | Supplement 33Labeling · Priority review | Approved | None posted |
| Apr 7, 1986 | Supplement 32Labeling · Priority review | Approved | None posted |
| Mar 1, 1984 | Supplement 31Labeling · Priority review | Approved | None posted |
| Dec 21, 1983 | Supplement 30Labeling · Priority review | Approved | None posted |
| Apr 28, 1983 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Mar 4, 1982 | Supplement 26Labeling · Priority review | Approved | None posted |
| Nov 5, 1979 | Supplement 25Labeling · Priority review | Approved | None posted |
| Mar 1, 1977 | Supplement 24Labeling · Priority review | Approved | None posted |
| Nov 22, 1976 | Supplement 23Labeling · Priority review | Approved | None posted |
| Jul 28, 1976 | Supplement 21Labeling · Priority review | Approved | None posted |
| Oct 19, 1961 | Original applicationNew dosage form · 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
