Data updated: Mar 10, 2026
DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE
Approved 1997-10-15
23
Indications
--
Phase 3 Trials
28
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1997-10-15
- Routes
- ORAL, INJECTION, NASAL
- Dosage Forms
- TABLET, INJECTABLE, SPRAY, METERED, SOLUTION
Companies
Teva GLAND FERRING AM REGENT SAGENT PHARMS INC UBI ABHAI LLC Dr. Reddy's Pfizer IMPAX LABS INC Sun Pharma BEDFORD Apotex Aurobindo Pharma HERITAGE PHARMA MEITHEAL NATCO PHARMA USA BAUSCH GLENMARK PHARMS LTD NOVAST LABS
Active Ingredient: DESMOPRESSIN ACETATE
Website: ↗
DESMOPRESSIN ACETATE Approval History
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What DESMOPRESSIN ACETATE Treats
23 FDA approvalsOriginally approved for its first indication in 1997 . Covers 23 distinct patient populations.
- Other (23)
Other
(23 approvals)- • Approved indication (Oct 1997)
- • Approved indication (Jan 1999)Letter
- • Approved indication (Feb 2000)Letter
- • Approved indication (Aug 2000)Letter
- • Approved indication (Jul 2005)Letter
- • Approved indication (Jan 2006)
- • Approved indication (Mar 2006)
- • Approved indication (May 2008)Letter
- • Approved indication (Apr 2012)
- • Approved indication (Jan 2013)
- • Approved indication (Jun 2014)
- • Approved indication (May 2015)Letter
- • Approved indication (May 2017)
- • Approved indication (Aug 2017)Letter
- • Approved indication (Jan 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Jun 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Aug 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Mar 2024)
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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.
DESMOPRESSIN ACETATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.