Data updated: Mar 10, 2026
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE
Approved 1972-05-09
41
Indications
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1972-05-09
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE, ELIXIR, SYRUP
Companies
VALEANT PHARM INTL AVET LIFESCIENCES MICRO LABS Pfizer WATSON LABS FOSUN PHARMA MK LABS LNK PIONEER PHARMS Sun Pharma ALPHARMA US PHARMS PVT FORM PUREPAC PHARM KV PHARM Teva NEWTRON PHARMS BEL MAR LANNETT HEATHER LEDERLE VANGARD HALSEY GLAND IMPAX LABS Dr. Reddy's PERRIGO LYPHOMED ANABOLIC Hikma NEXGEN PHARMA INC MUTUAL PHARM SUPERPHARM CUMBERLAND SWAN WHITEWORTH TOWN PLSN CENCI ROXANE HERITAGE PHARMA NASKA ALRA BUNDY ELKINS SINN APP PHARMS PHARMOBEDIENT IVAX SUB TEVA PHARMS WEST-WARD PHARMS INT PHARM ASSOC SCIEGEN PHARMS
Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE
Website: ↗
DIPHENHYDRAMINE HYDROCHLORIDE Approval History
Loading approval history...
What DIPHENHYDRAMINE HYDROCHLORIDE Treats
41 FDA approvalsOriginally approved for its first indication in 1972 . Covers 41 distinct patient populations.
- Other (41)
Other
(41 approvals)- • Approved indication (May 1972)
- • Approved indication (May 1972)
- • Approved indication (Aug 1972)
- • Approved indication (Aug 1972)
- • Approved indication (Sep 1972)
- • Approved indication (Nov 1972)
- • Approved indication (Nov 1972)
- • Approved indication (Dec 1972)
- • Approved indication (Jan 1973)
- • Approved indication (Feb 1973)
- • Approved indication (Aug 1973)
- • Approved indication (Oct 1973)
- • Approved indication (Oct 1973)
- • Approved indication (Nov 1973)
- • Approved indication (Jan 1974)
- • Approved indication (Jan 1974)
- • Approved indication (Feb 1974)
- • Approved indication (Dec 1974)
- • Approved indication (Feb 1975)
- • Approved indication (Jun 1976)
- • Approved indication (Jul 1976)
- • Approved indication (Sep 1977)
- • Approved indication (Jan 1979)
- • Approved indication (Feb 1979)
- • Approved indication (Oct 1979)
- • Approved indication (Mar 1981)
- • Approved indication (Dec 1981)
- • Approved indication (Jan 1982)
- • Approved indication (Feb 1982)
- • Approved indication (Oct 1982)
- • Approved indication (Jan 1983)
- • Approved indication (Jan 1987)
- • Approved indication (Sep 1990)
- • Approved indication (Nov 1998)Letter
- • Approved indication (May 2002)Letter
- • Approved indication (Jul 2005)
- • Approved indication (Aug 2018)
- • Approved indication (Mar 2024)
- • Approved indication (Jun 2025) New
- • Approved indication (Aug 2025) New
- • Approved indication (Nov 2025) New
🔬
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.
DIPHENHYDRAMINE 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.