LITHOBID
Details
- Status
- Prescription
- First Approved
- 1979-04-27
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
LITHOBID Approval History
What LITHOBID Treats
1 FDA approvalsOriginally approved for its first indication in 1979 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 1979)
LITHOBID Boxed Warning
WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION )....
WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION ).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
LITHOBID FDA Label Details
ProWARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION )....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.