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  • TABLET;ORAL - 1MG
  • TABLET;ORAL - 2MG
  • INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INHALATION - 15.6MCG/INH
  • POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
  • SOLUTION;INHALATION - 25MCG/ML

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-9-2023-9584.pdf

FDA
09 Aug 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-for-week-of-june-28-2023-96236.pdf

FDA
28 Jun 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-14-2023-63954.pdf

FDA
14 Jun 2023

https://www.prnewswire.com/news-releases/endo-launches-prevduo-neostigmine-methylsulfate-and-glycopyrrolate-injection-the-first-and-only-fda-approved-neostigmineglycopyrrolate-combination-pre-filled-syringe-301847772.html

PR NEWSWIRE
12 Jun 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-8-2023-15780.pdf

FDA
08 Mar 2023

https://www.indianpharmapost.com/news/lupin-receives-approval-from-usfda-for-glycopyrrolate-injection-usp-13705

INDIAN PHARMA POST
10 Feb 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-4-2023-52000.pdf

FDA
04 Jan 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-28-2022-95999.pdf

FDA
28 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212871

FDA
28 Nov 2022

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-gets-usfda-nod-for-generic-version-of-glycopyrrolate-injection/articleshow/95223039.cms

INDIATIMES.COM/INDUSTRY/HEALTHCARE/BIOTECH/PHARMACEUTICALS/ALEMBIC-PHARMA-GETS-USFDA-NOD-FOR-GENERIC-VERSION-OF-GLYCOPYRROLATE-INJECTION/ARTICLESHOW/95223039
01 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214635

FDA
26 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216407

FDA
21 Oct 2022

https://www.prnewswire.com/news-releases/piramal-critical-care-launches-first-to-market-generic-zinc-sulfate-injection-in-the-us-301608664.html

PRNEWSWIRE
19 Aug 2022

http://www.pharmafile.com/news/730650/nhs-scotland-recommends-chiesi-s-trimbow-asthma

PHARMAFILE
18 Aug 2022

https://www.businesswire.com/news/home/20220725005542/en

BUSINESSWIRE
25 Jul 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213698

FDA
05 Jul 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212467

FDA
05 Jul 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-8-2022-1654674832.pdf

FDA
08 Jun 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-6-2022-1649740823.pdf

FDA
06 Apr 2022

https://www.ema.europa.eu/en/medicines/human/EPAR/riltrava-aerosphere

EMA
04 Feb 2022

http://www.pharmabiz.com/NewsDetails.aspx?aid=145064&sid=2

PHARMABIZ
06 Jan 2022

https://www.prnewswire.com/news-releases/endo-launches-first-generic-version-of-cuvposa-glycopyrrolate-oral-solution-301454073.html

PRNEWSWIRE
04 Jan 2022

https://www.biospace.com/article/releases/edenbridge-pharmaceuticals-announces-u-s-fda-approval-of-dartisla-odt-glycopyrrolate-orally-disintegrating-tablets/

BIOSPACE
17 Dec 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214213

FDA
16 Nov 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=143860&sid=2

PHARMABIZ
10 Nov 2021

https://www.zyduscadila.com/public/pdf/pressrelease/Zydus-Cadila-receives-final-approval-from-USFDA-for-Glycopyrrolate-Injection.pdf

ZYDUSCADILA
10 Nov 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212591

FDA
19 Oct 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-22-2021-1632297403.pdf

FDA
22 Sep 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=142343&sid=2

PHARMABIZ
06 Sep 2021

https://www.catalent.com/catalent-news/catalent-to-supply-edenbridge-pharmaceuticals-with-a-fast-dissolve-zydis-formulation-of-glycopyrrolate-intended-as-adjunctive-therapy-for-patients-with-peptic-ulcer/

PRESS RELEASE
10 Aug 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212802

FDA
06 Jul 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-17-2021-1613546616.pdf

FDA
17 Feb 2021

http://www.pharmafile.com/news/566249/european-approval-astrazenecas-trixeo-aerospace-moderate-severe-copd

PHARMAFILE
14 Dec 2020

https://www.raps.org/news-and-articles/news-articles/2020/7/fda-approvals-roundup-tecartus-breztri-aerosphere

Renee Matthews RAPS
30 Jul 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213238

FDA
16 Jul 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213238

FDA
10 Jul 2020

https://www.novartis.com/news/media-releases/novartis-phase-iii-iridium-data-lancet-respiratory-medicine-show-benefit-enerzair-breezhaler-qvm149-first-class-inhaled-labalamaics-combination-uncontrolled

PRESS RELEASE
10 Jul 2020

http://www.pharmabiz.com/NewsDetails.aspx?aid=129121&sid=2

PHARMABIZ
25 Jun 2020

https://www.astrazeneca.com/media-centre/press-releases/2020/bevespi-aerosphere-approved-in-china-for-patients-with-copd.html

PRESS RELEASE
18 May 2020

http://www.pmlive.com/pharma_news/novartis_asthma_triple_heads_chmps_latest_meeting_1339751

Phil Taylor PMLIVE
05 May 2020

https://www.prnewswire.com/news-releases/sosei-heptares-notes-that-enerzair-breezhaler-qvm149-has-been-recommended-for-approval-in-the-european-union-for-treating-uncontrolled-asthma-301050859.html

PRNEWSWIRE
01 May 2020

https://www.ema.europa.eu/en/news/first-triple-combination-therapy-asthma-optional-electronic-sensor

EMA
30 Apr 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-8-2020-1586323768.pdf

FDA
08 Apr 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-26-2020-1582696769.pdf

FDA
26 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210083

FDA
25 Feb 2020

https://www.prnewswire.com/news-releases/lilly-announces-agreement-to-acquire-dermira-300984850.html

PR NEWSWIRE
11 Jan 2020

https://www.hikma.com/newsroom/article-i4595-civica-rx-and-hikma-announce-shipments-of-heparin-and-seven-other-essential-injectable-medicines/

PRESS RELEASE
10 Dec 2019

https://www.prnewswire.com/news-releases/sosei-heptares-announces-that-the-copd-treatment-ultibro-breezhaler-has-been-included-in-the-national-reimbursement-drug-list-in-china-300966545.html

PR NEWSWIRE
28 Nov 2019

http://www.pharmabiz.com/NewsDetails.aspx?aid=119112&sid=2

PHARMABIZ
02 Nov 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210246

FDA
29 Oct 2019
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