AMANTADINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 1987-01-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SYRUP, CAPSULE, EXTENDED RELEASE
Companies
AMANTADINE HYDROCHLORIDE Approval History
What AMANTADINE HYDROCHLORIDE Treats
2 indicationsAMANTADINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Influenza A
- Parkinsonism
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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.
AMANTADINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.