FDA — authorised 11 August 1961
- Application: NDA012827
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: ROBINUL FORTE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SUN-101 via eFlow nebulizer in United States
FDA authorised SUN-101 via eFlow nebulizer on 11 August 1961
Marketing authorisations
FDA — authorised 25 August 1981
- Application: ANDA086900
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1981
- Application: ANDA086902
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- 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 10 June 1987
- Application: ANDA086178
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLYCOPYRROLATE
- Indication: TABLET — ORAL
- 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 21 September 2011
- Application: ANDA090963
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 October 2011
- Application: ANDA090020
- Marketing authorisation holder: OXFORD PHARMS
- 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 15 April 2013
- Application: ANDA202675
- Marketing authorisation holder: AUROBINDO PHARMA
- 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: NDA207923
- Marketing authorisation holder: NOVARTIS
- Local brand name: SEEBRI NEOHALER
- Indication: POWDER — INHALATION
- 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 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
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- 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 5 December 2017
- Application: NDA208437
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Local brand name: LONHALA MAGNAIR KIT
- Indication: SOLUTION — INHALATION
- 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
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- 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 30 September 2019
- Application: ANDA212612
- Marketing authorisation holder: GLAND
- 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
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- 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: NIVAGEN PHARMS INC
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 2021
- Application: ANDA214213
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: GLYCOPYRROLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 December 2021
- Application: NDA215019
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Local brand name: DARTISLA ODT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- 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: ANDA212467
- Marketing authorisation holder: SUVEN PHARMS
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 5 July 2022
- Application: ANDA213698
- Marketing authorisation holder: ANNORA PHARMA
- 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 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
- Local brand name: GLYCOPYRROLATE
- Indication: SOLUTION — ORAL
- Status: approved
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 27 October 2025
- Application: ANDA219267
- Marketing authorisation holder: AJENAT PHARMS
- 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: ANDA088475
- Marketing authorisation holder: ABRAXIS PHARM
- 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
Frequently asked questions
Is SUN-101 via eFlow nebulizer approved in United States?
Yes. FDA authorised it on 11 August 1961; FDA authorised it on 25 August 1981; FDA authorised it on 25 August 1981.
Who is the marketing authorisation holder for SUN-101 via eFlow nebulizer in United States?
CASPER PHARMA LLC holds the US marketing authorisation.