Data updated: Mar 10, 2026
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
CODEINE PHOSPHATE
Approved 1984-10-31
8
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-10-31
- Routes
- ORAL
- Dosage Forms
- SYRUP
Companies
Website: ↗
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE Approval History
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What PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE Treats
8 FDA approvalsOriginally approved for its first indication in 1984 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Oct 1984)
- • Approved indication (Dec 1984)
- • Approved indication (Dec 1988)
- • Approved indication (Aug 1997)
- • Approved indication (Mar 2010)Letter
- • Approved indication (Jun 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Oct 2020)
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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 AND CODEINE PHOSPHATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.