NDA 12301, held by Bausch. Chlordiazepoxide Hydrochloride.
As of Nov 13, 2026, NDA 12301 (Librium), held by Bausch, was first approved by FDA on Jul 21, 1961, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 1961 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Librium100MG/AMP · injectable;injection | Chlordiazepoxide Hydrochloride | Discontinued |
| May 7, 2002 | Supplement 23Labeling · Standard review | Approved | |
| Dec 28, 1998 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1994 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1992 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1985 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 29, 1985 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1985 | Supplement 17Labeling | Approved | None posted |
| Feb 3, 1983 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1980 | Supplement 14Labeling | Approved | None posted |
| May 28, 1980 | Supplement 13Labeling | Approved | None posted |
| Oct 25, 1979 | Supplement 12Labeling | Approved | None posted |
| Jul 20, 1979 | Supplement 11Labeling | Approved | None posted |
| Nov 6, 1978 | Supplement 10Labeling | Approved | None posted |
| Dec 14, 1977 | Supplement 8Labeling | Approved | None posted |
| Jul 21, 1961 | Original applicationNew dosage form · 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
