Data updated: Mar 10, 2026
GLYCOPYRROLATE
GLYCOPYRROLATE
Approved 1981-08-25
54
Indications
--
Phase 3 Trials
44
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1981-08-25
- Routes
- INJECTION, Injection, ORAL, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- INJECTABLE, Injectable, TABLET, SOLUTION
Companies
WATSON LABS QUAD PHARMS ALEMBIC APPCO PRINSTON INC SUVEN PHARMS Aurobindo Pharma AMNEAL MSN PH HEALTH AM REGENT Pfizer VELZEN PHARMA PVT EUGIA PHARMA CAPLIN UMEDICA MEITHEAL Fresenius Kabi BIONPHARMA LGM PHARMA SAGENT OMNIVIUM PHARMS GRANULES SOMERSET THERAPS LLC Hikma CHARTWELL RX Apotex PIRAMAL CRITICAL XIROMED Teva REGCON HOLDINGS Novartis Lupin RISING Sun Pharma ABRAXIS PHARM OXFORD PHARMS NATCO QUAGEN MANKIND PHARMA AJENAT PHARMS ZYDUS PHARMS SCIEGEN PHARMS GLAND ACCORD HLTHCARE ANNORA PHARMA
Active Ingredient: GLYCOPYRROLATE
Website: ↗
GLYCOPYRROLATE Approval History
Loading approval history...
What GLYCOPYRROLATE Treats
54 FDA approvalsOriginally approved for its first indication in 1981 . Covers 54 distinct patient populations.
- Other (54)
Other
(54 approvals)- • Approved indication (Aug 1981)
- • Approved indication (Sep 1985)
- • Approved indication (Jul 1986)
- • Approved indication (Jun 1988)
- • Approved indication (Sep 1991)
- • Approved indication (Dec 2004)
- • Approved indication (Aug 2006)
- • Approved indication (Mar 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Mar 2009)
- • Approved indication (Aug 2009)
- • Approved indication (Sep 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Mar 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Feb 2014)
- • Approved indication (Jun 2016)
- • Approved indication (Jan 2017)Letter
- • Approved indication (Jun 2017)
- • Approved indication (Jun 2017)Letter
- • Approved indication (Oct 2017)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Mar 2019)
- • Approved indication (May 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Aug 2021)Letter
- • Approved indication (Oct 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Apr 2022)Label Letter
- • Approved indication (Jul 2022)Letter
- • Approved indication (Oct 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Feb 2023)
- • Approved indication (Feb 2023)
- • Approved indication (Jul 2024)
- • Approved indication (Aug 2024)
- • Approved indication (Aug 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Dec 2024)
- • Approved indication (Apr 2025) New
- • Approved indication (Jul 2025) NewLabel Letter
- • Approved indication (Oct 2025) New
- • Approved indication (Dec 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.
GLYCOPYRROLATE 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.