Treats bipolar I disorder. ANDA 70755, held by Pai Holdings Pharm. Lithium Citrate.
As of Nov 14, 2026, ANDA 70755 (Lithium Citrate), held by Pai Holdings Pharm, was first approved by FDA on May 21, 1986, with 13 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 |
|---|---|---|---|
| May 21, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lithium CitrateEQ 300MG CARBONATE/5ML · syrup;oral | Lithium Citrate | Rx |
| Oct 13, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 13, 2022 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 28, 2008 | Supplement 13Labeling | Approved | None posted |
| Apr 22, 1997 | Supplement 9Labeling | Approved | None posted |
| Feb 5, 1996 | Supplement 8Labeling | Approved | None posted |
| Aug 12, 1994 | Supplement 7Labeling | Approved | None posted |
| Aug 12, 1994 | Supplement 18Labeling | Approved | None posted |
| Aug 29, 1990 | Supplement 6Labeling | Approved | None posted |
| Mar 27, 1989 | Supplement 5Labeling | Approved | None posted |
| Mar 25, 1987 | Supplement 3Manufacturing | Approved | None posted |
| Mar 25, 1987 | Supplement 4Manufacturing | Approved | None posted |
| Feb 17, 1987 | Supplement 2Labeling | Approved | None posted |
| Nov 10, 1986 | Supplement 1Labeling | Approved | None posted |
| May 21, 1986 | 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
