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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 20MG
  • TABLET;ORAL - 5MG
  • TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML
  • TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG
  • TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG
  • TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG
  • TABLET, EXTENDED RELEASE;ORAL - 18MG
  • TABLET, EXTENDED RELEASE;ORAL - 27MG
  • TABLET, EXTENDED RELEASE;ORAL - 36MG
  • TABLET, EXTENDED RELEASE;ORAL - 54MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 10MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 20MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 30MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 40MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 50MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 60MG
  • SOLUTION;ORAL - 10MG/5ML
  • SOLUTION;ORAL - 5MG/5ML
  • TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.prnewswire.com/news-releases/alora-pharmaceuticals-llc-announces-the-availability-of-once-daily-relexxii-for-the-treatment-of-attention-deficit-hyperactivity-disorder-adhd-302017993.html

PR NEWSWIRE
19 Dec 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-02-2022-1646291076.pdf

FDA
02 Mar 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215688

FDA
01 Dec 2021

https://www.moneycontrol.com/news/business/dr-reddys-launches-generic-add-drug-in-us-market-5792731.html

Brokerage Nahin MONEYCONTROL
02 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205135

FDA FDA
22 Aug 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212697

FDA
30 Jul 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213567

FDA
15 Jun 2020

https://business.financialpost.com/pmn/press-releases-pmn/business-wire-news-releases-pmn/ironshore-to-present-a-dose-conversion-poster-at-the-2020-american-society-of-clinical-psychopharmacology-virtual-scientific-poster-session

BUSINESS
08 Jun 2020

https://www.businesswire.com/news/home/20200512005104/en

BUSINESSWIRE
12 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210764

FDA
14 Apr 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-19-2020-1582176609.pdf

FDA
20 Feb 2020

https://www.businesswire.com/news/home/20191104005201/en/Ironshore-Present-Data-Pivotal-Trial-JORNAY-PM%E2%84%A2/?feedref=JjAwJuNHiystnCoBq_hl-QyNsUQ29c24MKpwrFSKUOTZQK86VRF04E6aMvZHPoaH7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LP6oD-t3eB0qV-nJQ-WeFyCEq7XOd8em_Uy42DWNTo2Mw==

BIOSPACE
04 Nov 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-23-2019-1571893469.pdf

FDA
24 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211779

FDA
08 Oct 2019

https://www.thehindubusinessline.com/companies/granules-gets-usfda-nod-for-adhd-treatment-drug/article27259903.ece

THEHINDUBUSINESSLINE
27 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211918

FDA
29 Apr 2019

https://www.in-pharmatechnologist.com/Article/2019/03/11/Adlon-s-ADHD-treatment-approved-but-with-black-box-warning

Maggie Lynch IN-PHARMATECHNOLOGIST
11 Mar 2019

https://www.biospace.com/article/releases/adlon-therapeutics-l-p-announces-fda-approval-for-adhansia-xr-methylphenidate-hcl-extended-release-capsules-cii-for-the-treatment-of-adhd/

BIOSPACE
01 Mar 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208737

FDA
01 Feb 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208861

FDA
15 Dec 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210818

FDA
30 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210992

FDA
24 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209276

FDA
02 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210139

FDA
05 Oct 2018

https://seekingalpha.com/article/4207220-osmotica-pharmaceuticals-files-raise-capital-u-s-ipo?source=partner_newsnow

Donovan Jones SEEKING ALPHA
19 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206049

FDA
22 May 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-9-2018-1525842214.pdf

FDA
09 May 2018

https://www.pharmacompass.com/pdf/news/tris-pharma-receives-fda-warning-letter-1523422271.pdf

FDA
11 Apr 2018

https://www.in-pharmatechnologist.com/Article/2018/04/10/CMO-for-Pfizer-ADHD-drug-hit-with-US-FDA-warning

Dan Stanton IN PHARMATECHNOLOGIST
10 Apr 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-14-2018-1521002669.pdf

FDA
14 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209753

FDA
08 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200886

01 Mar 2018

https://www.prnewswire.com/news-releases/amneal-launches-methylphenidate-hydrochloride-extended-release-tablets-usp-cii-ab-rated-generic-for-concerta-300593208.html

PR NEWSWIRE
05 Feb 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207515

FDA
03 Feb 2018

https://www.reuters.com/article/us-health-adhd-pregnancy-defects/adhd-drug-tied-to-heart-defects-in-babies-idUSKBN1EU1ZY?feedType=RSS&feedName=healthNews

Lisa Rapaport REUTERS
08 Jan 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210354

FDA
05 Jan 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-27-2017-1514352313.pdf

FDA
27 Dec 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-1-2017-1509512060.pdf

FDA
01 Nov 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-27-2017-1506575777.pdf

FDA
28 Sep 2017

http://www.prnewswire.com/news-releases/impax-announces-fda-approval-of-its-ab-rated-generic-concerta-methylphenidate-hydrochloride-extended-release-tablets-cii-300488895.html

PR NEWSWIRE
17 Jul 2017

http://www.reuters.com/article/us-concert-pharma-fda-idUSKBN19V1BN

Divya Grover REUTERS
10 Jul 2017

http://www.biospace.com/News/cancer-biotech-g1-therapeutics-grabs-105-million/456864/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

Alex Keown BIOSPACE
17 May 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206932

FDA
12 May 2017

https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-March-29-2017-1490767993.pdf

FDA
29 Mar 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208861

FDA
24 Mar 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207587

FDA
03 Mar 2017

http://www.prnewswire.com/news-releases/mylan-launches-generic-concerta-tablets-300384105.html

PR NEWSWIRE
30 Dec 2016

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207485

FDA
18 Nov 2016

http://www.fiercepharma.com/pharma/mylan-enters-concerta-generics-fray-after-fda-boots-mallinckrodt-lannett

Carly Helfand FIERCE PHARMA
26 Oct 2016

https://www.statnews.com/pharmalot/2016/10/24/generic-fda-concerta-adhd/

ED SILVERMAN STAT
25 Oct 2016
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