ANDA 76170, held by Heritage Pharma. Lithium Carbonate.
As of Nov 15, 2026, ANDA 76170 (Lithium Carbonate), held by Heritage Pharma, was first approved by FDA on Jun 10, 2002, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium Carbonate300MG · tablet, extended release;oral | Lithium Carbonate | Discontinued |
| Aug 19, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 17, 2003 | Supplement 3Labeling | Approved | None posted |
| Jun 10, 2002 | Original application | Approved |
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
