FDA — authorised 11 August 1961
- Application: NDA012827
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: ROBINUL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Glycopyrrolate in United States
FDA authorised Glycopyrrolate on 11 August 1961 · 7,595 US adverse-event reports
Marketing authorisations
FDA — authorised 6 February 1975
- Application: NDA017558
- Marketing authorisation holder: HIKMA
- Local brand name: ROBINUL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 December 1975
- Application: NDA014764
- Marketing authorisation holder: ROBINS AH
- Local brand name: ROBINUL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 September 1983
- Application: ANDA085563
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 1986
- Application: ANDA089335
- Marketing authorisation holder: AM REGENT
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 1988
- Application: ANDA089393
- Marketing authorisation holder: HOSPIRA
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 September 1991
- Application: ANDA081169
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 2004
- Application: ANDA040568
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 2006
- Application: ANDA040653
- Marketing authorisation holder: PH HEALTH
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2008
- Application: ANDA040847
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA040821
- Marketing authorisation holder: RISING
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 2009
- Application: ANDA040836
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2009
- Application: ANDA040844
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2012
- Application: ANDA091522
- Marketing authorisation holder: LGM PHARMA
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2012
- Application: ANDA090195
- Marketing authorisation holder: VELZEN PHARMA PVT
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2014
- Application: ANDA091182
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 2015
- Application: NDA207930
- Marketing authorisation holder: NOVARTIS
- Local brand name: UTIBRON NEOHALER
- Indication: POWDER — INHALATION
- Status: approved
FDA — authorised 29 October 2015
- Application: NDA207923
- Marketing authorisation holder: NOVARTIS
- Local brand name: SEEBRI NEOHALER
- Indication: POWDER — INHALATION
- Status: approved
FDA — authorised 20 June 2016
- Application: ANDA091413
- Marketing authorisation holder: NATCO
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2017
- Application: ANDA207201
- Marketing authorisation holder: APPCO
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 2017
- Application: ANDA208973
- Marketing authorisation holder: AMNEAL
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 2017
- Application: ANDA207639
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA209328
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 July 2018
- Application: NDA210997
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: GLYRX-PF
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 25 October 2018
- Application: ANDA210842
- Marketing authorisation holder: PIRAMAL CRITICAL
- Status: approved
FDA — authorised 31 October 2018
- Application: ANDA209024
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 November 2018
- Application: ANDA203657
- Marketing authorisation holder: ALEMBIC
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 2019
- Application: ANDA211705
- Marketing authorisation holder: CAPLIN
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 May 2019
- Application: ANDA211334
- Marketing authorisation holder: SANDOZ
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 February 2020
- Application: ANDA210083
- Marketing authorisation holder: SAGENT
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 July 2020
- Application: ANDA213238
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 2021
- Application: ANDA212227
- Marketing authorisation holder: XIROMED
- Status: approved
FDA — authorised 6 July 2021
- Application: ANDA212802
- Marketing authorisation holder: MEITHEAL
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 August 2021
- Application: ANDA204438
- Marketing authorisation holder: PH HEALTH
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 13 October 2021
- Application: ANDA212591
- Marketing authorisation holder: UMEDICA
- Status: approved
FDA — authorised 21 April 2022
- Application: NDA214919
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 5 July 2022
- Application: ANDA213698
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 5 July 2022
- Application: ANDA212467
- Marketing authorisation holder: SUVEN PHARMS
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 October 2022
- Application: ANDA215333
- Marketing authorisation holder: AMNEAL
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 2022
- Application: ANDA212871
- Marketing authorisation holder: OMNIVIUM PHARMS
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 February 2023
- Application: ANDA213655
- Marketing authorisation holder: LUPIN
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 February 2023
- Application: NDA216903
- Marketing authorisation holder: AZURITY
- Local brand name: PREVDUO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 February 2023
- Application: ANDA217354
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2023
- Application: ANDA202675
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 10 July 2024
- Application: ANDA212696
- Marketing authorisation holder: QUAGEN
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 2024
- Application: ANDA214735
- Marketing authorisation holder: GRANULES
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 October 2024
- Application: ANDA216297
- Marketing authorisation holder: SCIEGEN PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Glycopyrrolate for marketing in the United States on 13 June 2025. The approval was granted to SCIEGEN PHARMS under standard expedited pathway, with application number ANDA216297. The approved indication for Glycopyrrolate is listed in its labelling.
FDA — authorised 31 December 2024
- Application: ANDA214847
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 April 2025
- Application: ANDA216084
- Marketing authorisation holder: MSN
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 December 2025
- Application: ANDA220062
- Marketing authorisation holder: BIONPHARMA
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA089397
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: GLYCOPYRROLATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA085562
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 7,595
Most-reported reactions
- Dyspnoea — 1,505 reports (19.82%)
- Asthma — 955 reports (12.57%)
- Cough — 901 reports (11.86%)
- Pneumonia — 779 reports (10.26%)
- Wheezing — 772 reports (10.16%)
- Malaise — 554 reports (7.29%)
- Drug Ineffective — 553 reports (7.28%)
- Death — 530 reports (6.98%)
- Fatigue — 524 reports (6.9%)
- Chronic Obstructive Pulmonary Disease — 522 reports (6.87%)
Glycopyrrolate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Glycopyrrolate approved in United States?
Yes. FDA authorised it on 11 August 1961; FDA authorised it on 6 February 1975; FDA authorised it on 17 December 1975.
Who is the marketing authorisation holder for Glycopyrrolate in United States?
CASPER PHARMA LLC holds the US marketing authorisation.