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    • TABLET;ORAL - EQ 10MG BASE
    • TABLET;ORAL - EQ 2.5MG BASE
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    • CAPSULE;ORAL - EQ 10MG BASE;20MG
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    • TABLET;ORAL - EQ 5MG BASE;320MG
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    • TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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    NPPA releases draft version of retail price calculation for 5 formulations
    NPPA releases draft version of retail price calculation for 5 formulations

    http://www.pharmabiz.com/NewsDetails.aspx?aid=143433&sid=1

    PHARMABIZ
    23 Oct 2021
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    FDA Confirms Paragraph IV Patent Challenge of Consensi 210045 (Amlodipine Besylate and Celecoxib)Tablets
    FDA Confirms Paragraph IV Patent Challenge of Consensi 210045 (Amlodipine Besylate and Celecoxib)Tablets

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-consensi-210045-amlodipine-besylate-and-celecoxibtablets-1597494563.pdf

    FDA
    15 Aug 2020
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    Enforcement Report - Week of February 19, 2020
    Enforcement Report - Week of February 19, 2020

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

    FDA
    20 Feb 2020
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    Acharya Chemicals Fails EDQM Inspection
    Acharya Chemicals Fails EDQM Inspection

    https://www.pharmacompass.com/pdf/news/acharya-chemicals-fails-edqm-inspection-1574398606.pdf

    EDQM
    22 Nov 2019
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    The sartan saga: Recapping the recalls
    The sartan saga: Recapping the recalls

    https://www.in-pharmatechnologist.com/Article/2019/08/14/The-sartan-saga-Recapping-the-recalls

    Maggie Lynch IN-PHARMATECHNOLOGY
    15 Aug 2019
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    Cipla's Generic Amlodipine Besylate; Benazepril Hydrochloride Receives Approval in US
    Cipla's Generic Amlodipine Besylate; Benazepril Hydrochloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077215

    FDA
    07 Dec 2018
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    Sciegen Pharms' Amlodipine Besylate; Olmesartan Medoxomil Receives Approval in US
    Sciegen Pharms' Amlodipine Besylate; Olmesartan Medoxomil Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209010

    FDA
    05 Dec 2018
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    Valsartan products not currently recalled - Updated November 27, 2018
    Valsartan products not currently recalled - Updated November 27, 2018

    https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf

    FDA
    28 Nov 2018
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    Enforcement Report - Week of October 17, 2018
    Enforcement Report - Week of October 17, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-17-2018-1539751948.pdf

    FDA
    17 Oct 2018
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    Accord Healthcare's Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval in US
    Accord Healthcare's Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209600

    FDA
    05 Sep 2018
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    List of New Paragraph IV Certifications as of Aug 21, 2018
    List of New Paragraph IV Certifications as of Aug 21, 2018

    https://www.pharmacompass.com/pdf/news/List-of-New-Paragraph-IV-Certifications-as-of-Aug-21-2018-1534919998.pdf

    FDA
    21 Aug 2018
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    Prescription med: registration of new generics & biosimilars
    Prescription med: registration of new generics & biosimilars

    https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines

    TGA GOV
    05 Jun 2018
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    Sunshine Lake ‘s Generic Amlodipine Besylate Receives Approval In US
    Sunshine Lake ‘s Generic Amlodipine Besylate Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206524

    FDA
    05 May 2018
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    Micro Labs Generic Amlodipine Besylate: Olmesartan Medoxomil Receives Approval In US
    Micro Labs Generic Amlodipine Besylate: Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207435

    FDA
    07 Nov 2017
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    Zydus Pharm’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US
    Zydus Pharm’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207771

    FDA
    26 Sep 2017
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    Enforcement Report - Week of September 20, 2017
    Enforcement Report - Week of September 20, 2017

    https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-September-20-2017-1505884449.pdf

    FDA
    20 Sep 2017
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    Alkem Lab’s Generic Amlodipine Besylate:Olmesartan Medoxomil Receives Approval In US
    Alkem Lab’s Generic Amlodipine Besylate:Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209042

    FDA
    17 Aug 2017
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    Alembic Pharm’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US
    Alembic Pharm’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207073

    FDA
    21 Jul 2017
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    Glenmark Pharm’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US
    Glenmark Pharm’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207807

    FDA
    07 Jul 2017
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    Jubilant’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US
    Jubilant’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207450

    FDA
    18 May 2017
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    Aurobindo Pharma’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US
    Aurobindo Pharma’s Generic Amlodipine Besylate; Olmesartan Medoxomil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206906

    FDA
    17 May 2017
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    Alembic's Generic Amlodipine Besylate; Telmisartan Receives Approval In US
    Alembic's Generic Amlodipine Besylate; Telmisartan Receives Approval In US

    http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205234

    FDA
    18 Nov 2016
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    Teva's Generic Amlodipine; Hydrochlorothiazide & Olmesartan Medoxomil Received Approval In US
    Teva's Generic Amlodipine; Hydrochlorothiazide & Olmesartan Medoxomil Received Approval In US

    http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202491

    FDA
    03 Nov 2016
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    Torrent’s Generic Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Received Approval In US
    Torrent’s Generic Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Received Approval In US

    https://www.pharmacompass.com/pdf/news/torrents-generic-amlodipine-besylate-hydrochlorothiazide-olmesartan-medoxomil-received-approval-in-us-1477649441.pdf

    FDA
    26 Oct 2016
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    Teva’s Generic Amlodipine Besylate; Olmesartan Medoxomil Received Approval In US
    Teva’s Generic Amlodipine Besylate; Olmesartan Medoxomil Received Approval In US

    https://www.pharmacompass.com/pdf/news/tevas-generic-amlodipine-besylate-olmesartan-medoxomil-received-approval-in-us-1477649524.pdf

    FDA
    26 Oct 2016
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    Par’s Generic Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil
    Par’s Generic Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil

    https://www.pharmacompass.com/pdf/news/pars-genericamlodipine-besylate-hydrochlorothiazide-olmesartan-medoxomil-1478174900.pdf

    FDA
    26 Oct 2016
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    Invagen Pharms Generic Amlodipine Besylate; Valsartan Approved In US
    Invagen Pharms Generic Amlodipine Besylate; Valsartan Approved In US

    https://www.pharmacompass.com/pdf/news/invagen-pharms-generic-amlodipine-besylate-valsartan-approved-in-us-1475059407.pdf

    FDA
    16 Sep 2016
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    Polygen Pharms' Generic Amlodipine Besylate Approved In USA For Hypertension
    Polygen Pharms' Generic Amlodipine Besylate Approved In USA For Hypertension

    https://www.pharmacompass.com/pdf/news/polygen-pharms-generic-amlodipine-besylate-approved-in-usa-for-hypertension-1468664590.pdf

    FDA
    11 Jul 2016
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    Aurobindo's Generic Amlodipine Besylate; Valsartan approved in US for Hypertension
    Aurobindo's Generic Amlodipine Besylate; Valsartan approved in US for Hypertension

    https://www.pharmacompass.com/pdf/news/aurobindos-generic-amlodipine-besylate-valsartan-approved-in-us-for-hypertension-1461749000.pdf

    FDA
    25 Apr 2016
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    New Novartis meds help relieve Gleevec generics pain
    New Novartis meds help relieve Gleevec generics pain

    http://www.fiercepharma.com/pharma/new-novartis-meds-help-relieve-gleevec-generics-pain

    Tracy Staton FIERCE PHARMA
    21 Apr 2016
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    Kitov's combo arthritis drug clears Phase III with an FDA filing on deck
    Kitov's combo arthritis drug clears Phase III with an FDA filing on deck

    http://www.fiercebiotech.com/story/kitov-pharmas-combo-arthritis-drug-clears-phase-iii-fda-filing-deck/2015-12-15

    Damian Garde FIERCE BIOTECH
    15 Dec 2015
    Share Share
    Advera Health Analytics: Merck statins linked to more muscle side effects than rest of class
    Advera Health Analytics: Merck statins linked to more muscle side effects than rest of class

    http://www.fiercepharma.com/story/advera-health-analytics-merck-statins-linked-more-muscle-side-effects-rest/2015-09-14

    Emily Wasserman FIERCE PHARMA
    15 Sep 2015
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    Dr Reddy’s shares fall as its arm recalls Amlodipine besylate and Atorvastatin calcium tablets in US
    Dr Reddy’s shares fall as its arm recalls Amlodipine besylate and Atorvastatin calcium tablets in US

    http://www.financialexpress.com/article/markets/indian-markets/dr-reddys-shares-fall-as-its-arm-recalls-amlodipine-besylate-and-atorvastatin-calcium-tablets-in-us/131678/?

    FE Online FINANCIAL EXPRESS
    06 Sep 2015
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    Anvisa approved amlodipine besylate for the treatment of hyperytension
    Anvisa approved amlodipine besylate for the treatment of hyperytension

    http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2015/anvisa+aprova+generico+inedito+para+o+tratamento+de+hipertensao

    Press Release ANVISA
    03 Sep 2015
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    Pediatric Exclusivity: Amazingly Powerful, Essentially Ironclad . . . and Often Overlooked
    Pediatric Exclusivity: Amazingly Powerful, Essentially Ironclad . . . and Often Overlooked

    http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/07/pediatric-exclusivity-amazingly-powerful-essentially-ironclad-and-often-overlooked.html

    Kurt R. Karst FDA LAW BLOG
    07 Jul 2015
    Share Share
    Dr. Reddy Initiates Class III Recall of Amlodipine besylate and Atorvastatin calcium tablets due to Subpotent drug
    Dr. Reddy Initiates Class III Recall of Amlodipine besylate and Atorvastatin calcium tablets due to Subpotent drug

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1146-2015&w=06242015&lang=eng

    Press Release FDA
    19 Jun 2015
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    Lupin's Generic Amlodipine Besylate, Valsartan and Hydrochlorothiazide Approved in US For Hypertension
    Lupin's Generic Amlodipine Besylate, Valsartan and Hydrochlorothiazide Approved in US For Hypertension

    FDA
    03 Jun 2015
    Share Share
    Alembic's Generic Amlodipine Besylate And Valsartan Approved in USA For Hypertension
    Alembic's Generic Amlodipine Besylate And Valsartan Approved in USA For Hypertension

    http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202713Orig1s000ltr.pdf

    Press Release FDA
    03 Apr 2015
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    Qualitest Pharmaceuticals, Ongoing Class II recall of AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 because of Failed tablet specifications: One lot was found to contain oversized tablets.
    Qualitest Pharmaceuticals, Ongoing Class II recall of AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 because of Failed tablet specifications: One lot was found to contain oversized tablets.

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0397-2015&w=03112015&lang=eng

    FDA
    11 Mar 2015
    Share Share
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