Data updated: Mar 10, 2026
LITHIUM CARBONATE
LITHIUM CARBONATE
Approved 1970-04-06
27
Indications
--
Phase 3 Trials
55
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1970-04-06
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, EXTENDED RELEASE, TABLET
Companies
PHARMOBEDIENT ABLE ALEMBIC LTD UNIQUE Apotex Hikma ALEMBIC HERITAGE PHARMA GLENMARK PHARMS LTD GLENMARK PHARMS INC Pfizer Sun Pharma WATSON LABS HETERO LABS LTD III USL PHARMA
Active Ingredient: LITHIUM CARBONATE
Website: ↗
LITHIUM CARBONATE Approval History
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What LITHIUM CARBONATE Treats
27 FDA approvalsOriginally approved for its first indication in 1970 . Covers 27 distinct patient populations.
- Other (27)
Other
(27 approvals)- • Approved indication (Apr 1970)
- • Approved indication (Nov 1980)
- • Approved indication (Jan 1982)
- • Approved indication (Sep 2001)Letter
- • Approved indication (Jun 2002)Label Letter
- • Approved indication (Jun 2002)
- • Approved indication (Apr 2003)
- • Approved indication (Jun 2003)
- • Approved indication (Aug 2003)
- • Approved indication (Jan 2004)
- • Approved indication (Jun 2004)
- • Approved indication (Oct 2004)
- • Approved indication (Nov 2004)
- • Approved indication (Apr 2008)
- • Approved indication (Jan 2009)
- • Approved indication (Feb 2009)
- • Approved indication (Sep 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Jun 2012)
- • Approved indication (Aug 2012)
- • Approved indication (Jun 2015)
- • Approved indication (Jul 2015)
- • Approved indication (Sep 2016)
- • Approved indication (Jun 2017)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LITHIUM CARBONATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.