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  • SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
  • SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216561

FDA
29 Nov 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-7-2023-80553.pdf

FDA
07 Jun 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-bets-on-respiratory-drug-licensing-deals-to-improve-business/articleshow/94232059.cms

Viswanath Pilla ECONOMIC TIMES
16 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216576

FDA
25 Jul 2022

https://www.businesswire.com/news/home/20220712005124/en

BUSINESSWIRE
12 Jul 2022

https://www.lawyer-monthly.com/2021/10/bayer-and-meda-sue-apotex-over-proposed-astepro-allergy-generic/

LAWYER-MONTHLY
09 Oct 2021

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-astepro-allergy-otc-21382-azelastine-hydrochloride-2055mcg20ml-nasal-spray-1633682847.pdf

FDA
06 Oct 2021

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-childrens-astepro-allergy-otc-21382-azelastine-hydrochloride-2055mcg20ml-nasal-spray-1633682925.pdf

FDA
06 Oct 2021

https://www.fiercepharma.com/pharma/no-more-prescriptions-bayer-turns-allergies-drug-over-counter-fda-nod-for-astepro

Angus Liu FIERCEPHARMA
19 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212775

FDA
17 Nov 2020

https://www.biospace.com/article/releases/cebina-reports-positive-findings-on-the-potency-of-azelastine-a-widely-used-anti-histamine-as-anti-covid-19-approach/

BIOSPACE
17 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212289

FDA
13 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210092

FDA
29 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210032

FDA
28 Aug 2019

https://www.globenewswire.com/news-release/2019/08/26/1906706/0/en/Akorn-Receives-FDA-Approval-for-Azelastine-Hydrochloride-Nasal-Spray-0-15.html

GLOBENEWSWIRE
26 Aug 2019

https://www.pharmacompass.com/pdf/news/akorn-inc-receives-fda-warning-letter-1562734261.pdf

FDA
09 Jul 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207610

FDA
22 May 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-13-2019-1550065023.pdf

FDA
13 Feb 2019

https://www.raps.org/news-and-articles/news-articles/2018/11/fda-hands-akorn-483-over-gmp-issues-at-new-jersey?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%205%20November

Michael Mezher RAPS
06 Nov 2018

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm624887.pdf

FDA
05 Nov 2018

https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-August-15-2018-1534336681.pdf

FDA
15 Aug 2018

https://www.thepharmaletter.com/in-brief/brief-ftc-imposes-conditions-on-amneal-acquisition-of-impax

PHARMA LETTER
11 Jul 2018

https://www.ftc.gov/news-events/press-releases/2018/07/ftc-approves-final-order-imposing-conditions-merger-generic-drug

FTC GOV
11 Jul 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-21-2018-1519194777.pdf

FDA
21 Feb 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208199

FDA
19 Dec 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207243

FDA
26 Sep 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208156

FDA
22 Aug 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091409

FDA
17 Aug 2017

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-cadila-gets-usfda-nod-for-blood-pressure-drug/articleshow/60083383.cms

ECONOMIC TIMES
16 Aug 2017

http://www.in-pharmatechnologist.com/Processing/Mylan-confirms-plan-to-close-Meda-Soma-plant-in-Illinois

G. MacDonald IN PHARMATECHNOLOGIST
28 Mar 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202609

FDA
17 Mar 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207243

FDA
09 Dec 2016

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM440188.pdf

FDA
23 Mar 2015
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