Treats bipolar I disorder. ANDA 79139, held by Glenmark Pharms Ltd. Lithium Carbonate.
As of Nov 15, 2026, ANDA 79139 (Lithium Carbonate), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 3, 2009, with 8 approved supplements and 0 published complete response letters.
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older Maintenance treatment in patients 7 years and older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2009 | Original application | Approved | None posted |
| Lithium Carbonate150MG · capsule;oral | Lithium Carbonate | Rx |
| Lithium Carbonate300MG · capsule;oral | Lithium Carbonate | Rx |
| Lithium Carbonate600MG · capsule;oral | Lithium Carbonate | Rx |
| May 8, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 11, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 11, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 3, 2018 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 3, 2015 | Supplement 2Labeling | Approved | None posted |
| Jul 25, 2012 | Supplement 5Manufacturing | Approved | None posted |
| Mar 6, 2012 | Supplement 4Labeling | Approved | None posted |
| Sep 7, 2010 | Supplement 3Manufacturing | Approved | None posted |
| Feb 3, 2009 | 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
