Data updated: Mar 10, 2026
PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE
Approved 1975-10-20
31
Indications
--
Phase 3 Trials
50
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1975-10-20
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, CAPSULE, EXTENDED RELEASE
Companies
Teva VIRTUS WATSON LABS VITARINE INWOOD LABS Novartis FERNDALE LABS GRAHAM DM KV PHARM IVAX PHARMS CHARTWELL ACERTIS PHARMS PVT FORM CHARTWELL RX IVAX SUB TEVA PHARMS MFG CHEMISTS UPSHER SMITH LABS KVK TECH USL PHARMA NEXGEN PHARMA INC NUMARK SOLVAY MPP PHARMA ELITE LABS INC
Active Ingredient: PHENDIMETRAZINE TARTRATE
Website: ↗
PHENDIMETRAZINE TARTRATE Approval History
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What PHENDIMETRAZINE TARTRATE Treats
31 FDA approvalsOriginally approved for its first indication in 1975 . Covers 31 distinct patient populations.
- Other (31)
Other
(31 approvals)- • Approved indication (Oct 1975)
- • Approved indication (Jul 1976)
- • Approved indication (Jan 1977)
- • Approved indication (Jan 1977)
- • Approved indication (Jan 1977)
- • Approved indication (May 1977)
- • Approved indication (May 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Aug 1977)
- • Approved indication (Aug 1977)
- • Approved indication (Sep 1977)
- • Approved indication (Nov 1977)
- • Approved indication (Feb 1978)
- • Approved indication (May 1978)
- • Approved indication (May 1978)
- • Approved indication (Jun 1978)
- • Approved indication (Jun 1978)
- • Approved indication (Jul 1978)
- • Approved indication (Apr 1979)
- • Approved indication (May 1981)
- • Approved indication (Sep 1981)
- • Approved indication (Nov 1981)
- • Approved indication (Aug 1982)
- • Approved indication (Sep 1982)
- • Approved indication (Oct 1982)
- • Approved indication (Jun 1983)
- • Approved indication (Sep 1983)
- • Approved indication (Oct 1991)
- • Approved indication (Jan 2008)
- • Approved indication (Aug 2010)
- • Approved indication (Dec 2017)
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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.
PHENDIMETRAZINE TARTRATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.