Data updated: Mar 10, 2026
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ATROPINE SULFATE
Approved 1977-06-03
24
Indications
--
Phase 3 Trials
48
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1977-06-03
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
Companies
INWOOD LABS PVT FORM HEATHER ASCOT CHARTWELL RX R AND S PHARMA UNICHEM SPECGX LLC LANNETT PARKE DAVIS UPSHER SMITH LABS ABLE PHARMOBEDIENT WATSON LABS VALEANT PHARM INTL ANI PHARMS WINDER LABS LLC ROXANE Hikma KV PHARM USL PHARMA Dr. Reddy's LEADING STRIDES PHARMA INTL Sun Pharma LEDERLE FOSUN PHARMA
Website: ↗
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Approval History
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What DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Treats
24 FDA approvalsOriginally approved for its first indication in 1977 . Covers 24 distinct patient populations.
- Other (24)
Other
(24 approvals)- • Approved indication (Jun 1977)
- • Approved indication (Jul 1977)
- • Approved indication (Nov 1977)
- • Approved indication (Jan 1978)
- • Approved indication (Feb 1978)
- • Approved indication (Mar 1978)
- • Approved indication (Jun 1978)
- • Approved indication (Dec 1978)
- • Approved indication (Oct 1979)
- • Approved indication (Jul 1981)
- • Approved indication (Aug 1981)
- • Approved indication (Mar 1982)
- • Approved indication (Mar 1982)
- • Approved indication (May 1982)
- • Approved indication (Mar 1997)
- • Approved indication (May 2000)
- • Approved indication (Nov 2000)Letter
- • Approved indication (Aug 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Feb 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Jan 2021)
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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.
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.