Data updated: Mar 10, 2026
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE
Approved 1973-03-06
53
Indications
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1973-03-06
- Routes
- ORAL, INJECTION, RECTAL
- Dosage Forms
- TABLET, INJECTABLE, SYRUP, SUPPOSITORY
Companies
IVAX SUB TEVA PHARMS Pfizer TABLICAPS KV PHARM WATSON LABS STRIDES PHARMA WATSON LABS INC QUAGEN SUN PHARMA CANADA XGEN PHARMS IMPAX LABS AMNEAL PHARMS Teva Novartis MARSAM PHARMS LLC PVT FORM Sun Pharma CHARTWELL RX ABLE ZYDUS PHARMS USA KVK TECH Hikma EPIC PHARMA LLC RISING BEDFORD LABS ABBOTT WHITEWORTH TOWN PLSN AMNEAL PHARMS NY AM REGENT PHARM ASSOC ANNORA PHARMA PADAGIS ISRAEL PRINSTON INC CHARTWELL MOLECULAR Aurobindo Pharma COSETTE Viatris WOCKHARDT BIO AG
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Website: ↗
PROMETHAZINE HYDROCHLORIDE Approval History
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What PROMETHAZINE HYDROCHLORIDE Treats
53 FDA approvalsOriginally approved for its first indication in 1973 . Covers 53 distinct patient populations.
- Other (53)
Other
(53 approvals)- • Approved indication (Mar 1973)
- • Approved indication (Sep 1973)
- • Approved indication (Sep 1973)
- • Approved indication (Sep 1973)
- • Approved indication (Oct 1973)
- • Approved indication (Jan 1974)
- • Approved indication (Jan 1974)
- • Approved indication (Aug 1974)
- • Approved indication (Feb 1975)
- • Approved indication (Jul 1975)
- • Approved indication (Jul 1976)
- • Approved indication (Jul 1976)
- • Approved indication (Sep 1976)
- • Approved indication (Oct 1976)
- • Approved indication (Mar 1977)
- • Approved indication (May 1977)
- • Approved indication (Sep 1977)
- • Approved indication (Sep 1978)
- • Approved indication (Sep 1985)
- • Approved indication (May 1988)
- • Approved indication (Sep 1994)
- • Approved indication (Sep 1998)Letter
- • Approved indication (Jun 2000)Label Letter
- • Approved indication (Feb 2002)
- • Approved indication (Aug 2002)Letter
- • Approved indication (Nov 2002)
- • Approved indication (Feb 2003)
- • Approved indication (Mar 2003)
- • Approved indication (Apr 2003)
- • Approved indication (Jun 2003)
- • Approved indication (Jun 2003)
- • Approved indication (Mar 2004)
- • Approved indication (Jul 2004)
- • Approved indication (Nov 2005)
- • Approved indication (Apr 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Oct 2006)
- • Approved indication (Nov 2006)
- • Approved indication (Apr 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Apr 2008)
- • Approved indication (May 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Mar 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Dec 2010)
- • Approved indication (Aug 2011)
- • Approved indication (Jun 2012)
- • Approved indication (Jun 2017)
- • Approved indication (Jul 2021)
- • Approved indication (Nov 2022)
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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.
PROMETHAZINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.