Data updated: Mar 10, 2026
PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE
Approved 1976-07-01
56
Indications
--
Phase 3 Trials
49
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1976-07-01
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, TABLET, ORALLY DISINTEGRATING
Companies
UPSHER SMITH LABS CHARTWELL RX Teva Aurobindo Pharma AUROLIFE PHARMA LLC NUVO PHARM ELITE LABS INC KVK TECH Novartis USL PHARMA INGENUS PHARMS LLC IVAX PHARMS VITARINE ELITE LABS Sun Pharma ABC HOLDING LANNETT DURAMED PHARMS BARR INVAGEN PHARMS ABLE WATSON LABS CAMALL LANNETT CO INC PURACAP LABS BLU PRINSTON INC KVK TECH INC ZYDUS PHARMS TG UNITED INC
Active Ingredient: PHENTERMINE HYDROCHLORIDE
Website: ↗
PHENTERMINE HYDROCHLORIDE Approval History
Loading approval history...
What PHENTERMINE HYDROCHLORIDE Treats
56 FDA approvalsOriginally approved for its first indication in 1976 . Covers 56 distinct patient populations.
- Other (56)
Other
(56 approvals)- • Approved indication (Jul 1976)
- • Approved indication (Mar 1977)
- • Approved indication (Apr 1978)
- • Approved indication (Apr 1978)
- • Approved indication (May 1978)
- • Approved indication (Dec 1978)
- • Approved indication (Sep 1980)
- • Approved indication (Jun 1981)
- • Approved indication (Apr 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Feb 1983)
- • Approved indication (Jul 1983)
- • Approved indication (Oct 1983)
- • Approved indication (Oct 1983)
- • Approved indication (Dec 1983)
- • Approved indication (Mar 1984)
- • Approved indication (Apr 1984)
- • Approved indication (May 1984)
- • Approved indication (Jun 1984)
- • Approved indication (Aug 1984)
- • Approved indication (Mar 1985)
- • Approved indication (Apr 1986)
- • Approved indication (Sep 1987)
- • Approved indication (Mar 1997)
- • Approved indication (May 1997)
- • Approved indication (Jun 1997)
- • Approved indication (Jun 1997)
- • Approved indication (Nov 1998)Label Letter
- • Approved indication (Aug 2001)Letter
- • Approved indication (Jan 2002)Letter
- • Approved indication (Jan 2003)
- • Approved indication (Jan 2003)
- • Approved indication (Mar 2003)
- • Approved indication (Oct 2003)
- • Approved indication (Apr 2005)
- • Approved indication (Aug 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Mar 2008)
- • Approved indication (Apr 2008)
- • Approved indication (Aug 2009)
- • Approved indication (Mar 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Jan 2011)
- • Approved indication (Jul 2011)
- • Approved indication (Sep 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Feb 2014)
- • Approved indication (Feb 2014)
- • Approved indication (May 2014)
- • Approved indication (Aug 2014)
- • Approved indication (Sep 2014)
- • Approved indication (Dec 2014)
- • Approved indication (Nov 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Jun 2017)Letter
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
PHENTERMINE HYDROCHLORIDE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.