Data updated: Jun 28, 2026
ALCOHOL 5% AND DEXTROSE 5% (alcohol) · B BRAUN
Other
Approved 1946-01-17
1
Indication
--
Phase 3 Trials
80
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1946-01-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ALCOHOL 5% AND DEXTROSE 5% Approval History
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Original
New Indication
New Form
Label Update
10 FDA actions from 1946 to 1985
Oct 1985 SUPPL
Label · Labeling
Jun 1985 SUPPL
Mfg · Manufacturing (CMC)
Jul 1984 SUPPL
Mfg · Manufacturing (CMC)
Oct 1982 SUPPL
Label
Jan 1982 SUPPL
Label
Oct 1980 SUPPL
Mfg
Feb 1978 SUPPL
Mfg
Jun 1977 SUPPL
Mfg
Jan 1946 ORIGINAL
Update
What ALCOHOL 5% AND DEXTROSE 5% Treats
1 FDA approvalsOriginally approved for its first indication in 1946 .
- Other (1)
Other
(1 approval)- • Approved indication (Jan 1946)
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Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00713492 | 080178 08-AA-0178 | Ph 1 | completed | Computer-Assisted Self-Administration of Ethanol |
| NCT04300751 results posted | 55176 R01DA016718 | Ph 1 | completed | The Behavioral Effects of Opioids and Alcohol |
| NCT04931095 | IRB00290015 1R01DA052295-01 | Ph 1 | completed | The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment |
| NCT06293040 | IRB00434441 R01DA052295 | Ph 1 | recruiting | Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment |
| NCT00295334 results posted | 250505 | Ph 2 | completed | Moderate Alcohol Intake Among Patients With Type 2 Diabetes |
| NCT06712602 | 90580 R01AA030774 | Ph 1 | recruiting | PT150 Drug for Use in Alcohol Use Disorder |
| NCT03503773 results posted | CR0014 | Ph 2 | completed | The TARGET BP OFF-MED Trial |
| NCT03575403 BED[IN]:36 results posted | 44796 R01AA026255 | Ph 1 | completed | Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate) |
| NCT04003402 | 8062-CL-2001 | Ph 1 | completed | A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects |
| NCT05389930 | 2022003195 R01AA029711 | Ph 2 | recruiting | Cannabis' Impact on Alcohol Consumption |
| NCT03699540 results posted | 43636 R21DA045101-02 | Ph 1 | completed | Marijuana Effects on Simulated Driving Performance |
| NCT06524609 | EGCG-TIPN | Ph 1, Ph 2 | recruiting | EGCG for the Prevention and Treatment of TIPN |
| NCT05273658 | 192048 | Ph 1, Ph 2 | withdrawn | Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests |
| NCT00559819 ALCDrive | MMoric111207 | Ph 3 | completed | Validation of Driving Simulator to Blood Alcohol Concentration Standards for Impaired Driving |
| NCT03416348 | OP150030 (Aim 1&2) OP150030 | Ph 1 | completed | Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2 |
| NCT03361384 | 14-068 R01AA022301 | Ph 1 | completed | Alcohol and Implicit Process in Sexual Risk Behavior in MSM |
| NCT03483636 | E2006-A001-009 | Ph 1 | completed | Study of Lemborexant-Alcohol Interaction in Healthy Subjects |
| NCT02046200 results posted | IVM UL1TR000124 | Ph 1, Ph 2 | completed | Development of Ivermectin for Alcohol Use Disorders |
| NCT01779024 results posted | 130043 13-AA-0043 | Ph 2 | completed | Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers |
| NCT02488889 VAR | 23FT-0102 | Ph 4 | withdrawn | Effects of Varenicline in Heavy Drinking Smokers |
| NCT02294266 | IMIMFTCL/MEF/2 | Ph 1 | completed | Mephedrone and Alcohol Interactions in Humans |
| NCT00879047 | R01AA018001 | Ph 1 | completed | Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection |
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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.
ALCOHOL 5% AND DEXTROSE 5% FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.