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    • TABLET, EXTENDED RELEASE;ORAL - EQ 100MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - EQ 200MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - EQ 25MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - EQ 50MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 100MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 200MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 25MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 50MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    Full View ScreenFull Screen View
    Lupin's Generic Metoprolol Succinate Receives Approval in the U.S.
    Lupin's Generic Metoprolol Succinate Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209272

    FDA
    15 Aug 2023
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    Granules' Generic Metoprolol Receives Approval in the U.S.
    Granules' Generic Metoprolol Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216509

    FDA
    07 Aug 2023
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    Granules' Generic Metoprolol Succinate Receives Approval in the U.S.
    Granules' Generic Metoprolol Succinate Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216916

    FDA
    12 Jun 2023
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    Enforcement Report - Week of February 22, 2023
    Enforcement Report - Week of February 22, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-22-2023-51785.pdf

    FDA
    22 Feb 2023
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    Accord's Generic Metoprolol Succinate Receives Approval in the U.S.
    Accord's Generic Metoprolol Succinate Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215637

    FDA
    18 Oct 2022
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    Sunshine's Generic Metoprolol Succinate Receives Approval in the U.S.
    Sunshine's Generic Metoprolol Succinate Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214004

    FDA
    26 Sep 2022
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    Melinta Tx Acquires U.S. Rights to TOPROL-XL from New American Therapeutics
    Melinta Tx Acquires U.S. Rights to TOPROL-XL from New American Therapeutics

    https://www.businesswire.com/news/home/20220406005971/en

    BUSINESSWIRE
    06 Apr 2022
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    Enforcement Report - Week of February 2, 2022
    Enforcement Report - Week of February 2, 2022

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-2-2022-1643778781.pdf

    FDA
    02 Feb 2022
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    Prinston's Generic Metoprolol Succinate Receives Approval in the U.S.
    Prinston's Generic Metoprolol Succinate Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210597

    FDA
    04 Jan 2022
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    Yichang Humanwell`s Generic Metoprolol Succinate Receives Approval in US
    Yichang Humanwell`s Generic Metoprolol Succinate Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213854

    FDA
    17 Feb 2021
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    Twi Pharms's Generic Metoprolol Succinate Receives Approval in US
    Twi Pharms's Generic Metoprolol Succinate Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207206

    FDA
    19 Dec 2018
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    Cipla's Generic Metoprolol Succinate Receives Approval in US
    Cipla's Generic Metoprolol Succinate Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207465

    FDA
    31 Oct 2018
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    Enforcement Report - Week of October 31, 2018
    Enforcement Report - Week of October 31, 2018

    https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-October-31-2018-1540974685.pdf

    FDA
    31 Oct 2018
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    GENETIC-AF Phase 2B Clinical Trial Results Presented at EU Society
    GENETIC-AF Phase 2B Clinical Trial Results Presented at EU Society

    https://globenewswire.com/news-release/2018/05/29/1513155/0/en/GENETIC-AF-Phase-2B-Clinical-Trial-Results-Presented-in-Late-Breaking-Presentation-at-European-Society-of-Cardiology-Heart-Failure-2018-World-Congress.html

    GLOBENEWSWIRE
    29 May 2018
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    Enforcement Report - Week of May 16, 2018
    Enforcement Report - Week of May 16, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-16-2018-1526446624.pdf

    FDA
    16 May 2018
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    Zydus Pharm`s Generic Metoprolol Succinate Receives Approval In US
    Zydus Pharm`s Generic Metoprolol Succinate Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203894

    FDA
    27 Mar 2018
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    Zydus Cadila gets USFDA nod for cardiac drug
    Zydus Cadila gets USFDA nod for cardiac drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-cadila-gets-usfda-nod-for-cardiac-drug/articleshow/63463889.cms

    ECONOMIC TIMES
    26 Mar 2018
    Share Share
    Growing drug resistance: Antibiotic consumption in India has skyrocketed
    Growing drug resistance: Antibiotic consumption in India has skyrocketed

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-cadila-gets-usfda-nod-for-cardiac-drug/articleshow/63463889.cms

    Prabha Raghavan ECONOMIC TIMES
    26 Mar 2018
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    Novast Lab's Generic Metoprolol Succinate Receives Approval In US
    Novast Lab's Generic Metoprolol Succinate Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204106

    FDA
    09 Feb 2018
    Share Share
    Aralez Completes Acquisition of Toprol-XL And its Authorized Generic from AZ
    Aralez Completes Acquisition of Toprol-XL And its Authorized Generic from AZ

    http://www.dddmag.com/news/2016/11/aralez-completes-acquisition-toprol-xl-and-its-authorized-generic-astrazeneca?

    DDDMAG
    02 Nov 2016
    Share Share
    Aralez Completes Acquisition Of Toprol-XL® And Its Authorized Generic
    Aralez Completes Acquisition Of Toprol-XL® And Its Authorized Generic

    http://www.prnewswire.com/news-releases/aralez-completes-acquisition-of-toprol-xl-and-its-authorized-generic-from-astrazeneca-300354012.html

    PR NEWS WIRE
    31 Oct 2016
    Share Share
    Aralez to Acquire From AstraZeneca U.S. Rights to Beta Blocker Toprol-XL®
    Aralez to Acquire From AstraZeneca U.S. Rights to Beta Blocker Toprol-XL®

    http://www.prnewswire.com/news-releases/aralez-to-acquire-from-astrazeneca-us-rights-to-beta-blocker-toprol-xl-300338569.html

    PRNEWSWIRE
    04 Sep 2016
    Share Share
    Design, Evaluation and Characterization of Rapidly Dissolving Oral Strips
    Design, Evaluation and Characterization of Rapidly Dissolving Oral Strips

    http://www.pharma-excipients.ch/2016/05/24/design-evaluation-and-characterization-ofrapidly-dissolving-oral-strips-of-metoprololsuccinate/

    PHARMA-EXCIPIENTS
    23 May 2016
    Share Share
    Health Canada requests quarantine of drugs linked to Polydrug Laboratories due to data integrity concerns
    Health Canada requests quarantine of drugs linked to Polydrug Laboratories due to data integrity concerns

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/53932a-eng.php

    HEALTHY CANADIANS
    25 Jun 2015
    Share Share
    India's Polydrug Labs fails EDQM inspection
    India's Polydrug Labs fails EDQM inspection

    https://www.pharmacompass.com/pdf/news/polydrug-laboratories-private-limited.pdf

    17 Jun 2015
    Share Share
    Another Punt Return Resolving 180-Day Exclusivity; This Time a True Post-MMA Case Made in the Context of Lamotrigine Orally Disintegrating Tablets
    Another Punt Return Resolving 180-Day Exclusivity; This Time a True Post-MMA Case Made in the Context of Lamotrigine Orally Disintegrating Tablets

    http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/05/another-punt-return-resolving-180-day-exclusivity-this-time-a-true-post-mma-case-made-in-the-context.html

    Kurt R. Karst FDA LAW BLOG
    18 May 2015
    Share Share
    Mylan recalling two injectable drugs made in India
    Mylan recalling two injectable drugs made in India

    http://www.fiercepharmamanufacturing.com/story/mylan-recalling-two-injectable-drugs-made-india/2015-03-31

    Eric Palmer FIERCE PHARMA MANUFACTURING
    31 Mar 2015
    Share Share
    Astrazeneca $7.9M Kickback Settlement Shows Risks of Payer Discounting
    Astrazeneca $7.9M Kickback Settlement Shows Risks of Payer Discounting

    http://www.fiercepharma.com/story/astrazeneca-79m-kickback-settlement-shows-risks-payer-discounting/2015-02-11

    Tracy Staton FIERCE PHARMA
    16 Feb 2015
    Share Share
    Dr Reddy`s Laboratories To Expand Capacity Of Manufacturing Units In Telangana
    Dr Reddy`s Laboratories To Expand Capacity Of Manufacturing Units In Telangana

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-laboratories-to-expand-capacity-of-manufacturing-units-in-telangana/articleshow/46122286.cms

    Press Trust Of India THE ECONOMIC TIMES
    04 Feb 2015
    Share Share
    Extended-Release Drugs Get Extra Scrutiny in U.S. Quality Focus
    Extended-Release Drugs Get Extra Scrutiny in U.S. Quality Focus

    http://www.bloomberg.com/news/2015-01-13/extended-release-drugs-get-extra-scrutiny-in-u-s-quality-focus.html

    Anna Edney BLOOMBERG
    13 Jan 2015
    Share Share
    Wockhardt Usa Inc., Ongoing Class III recall of Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA . because of Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
    Wockhardt Usa Inc., Ongoing Class III recall of Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA . because of Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0304-2015&w=12242014&lang=eng

    24 Dec 2014
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