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    • TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - 325MG;37.5MG
    • TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • CAPSULE, EXTENDED RELEASE;ORAL - 100MG
    • CAPSULE, EXTENDED RELEASE;ORAL - 150MG
    • CAPSULE, EXTENDED RELEASE;ORAL - 200MG
    • CAPSULE, EXTENDED RELEASE;ORAL - 300MG
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    Enforcement Report - Week of July 5, 2023
    Enforcement Report - Week of July 5, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-5-2023-58407.pdf

    FDA
    05 Jul 2023
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    Avenue Announces Regulatory Update Based on Type C Meeting IV Tramadol
    Avenue Announces Regulatory Update Based on Type C Meeting IV Tramadol

    https://www.globenewswire.com/news-release/2023/04/17/2648434/0/en/Avenue-Therapeutics-Announces-Regulatory-Update-Based-on-Type-C-Meeting-with-FDA-and-Next-Steps-in-the-Development-of-IV-Tramadol.html

    GLOBENEWSWIRE
    17 Apr 2023
    Share Share
    Tris Pharma Reports Positive Topline Data from Clinical Study of Cebranopadol
    Tris Pharma Reports Positive Topline Data from Clinical Study of Cebranopadol

    https://www.prnewswire.com/news-releases/tris-pharma-reports-positive-topline-data-from-clinical-study-of-investigational-pain-therapy-cebranopadol-showing-significantly-less-potential-for-abuse-versus-tramadol-and-oxycodone-301701284.html

    PRNEWSWIRE
    13 Dec 2022
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    Kowa Pharma to Publish PIII Data Supporting FDA Approval of SEGLENTIS
    Kowa Pharma to Publish PIII Data Supporting FDA Approval of SEGLENTIS

    https://www.businesswire.com/news/home/20220715005473/en

    BUSINESSWIRE
    19 Jul 2022
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    Neuraxpharm to increase branded business through upcoming acquisition of established products from Sanofi
    Neuraxpharm to increase branded business through upcoming acquisition of established products from Sanofi

    https://www.prnewswire.com/news-releases/neuraxpharm-to-increase-branded-business-through-upcoming-acquisition-of-established-products-from-sanofi-301584467.html

    PR NEWSWIRE
    12 Jul 2022
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    Avenue Tx Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol
    Avenue Tx Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol

    https://www.globenewswire.com/news-release/2022/02/16/2385819/0/en/Avenue-Therapeutics-Announces-Outcome-of-FDA-Advisory-Committee-Meeting-on-IV-Tramadol.html

    GLOBENEWSWIRE
    15 Feb 2022
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    Avenue Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA
    Avenue Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA

    https://www.globenewswire.com/news-release/2021/11/29/2342129/0/en/Avenue-Therapeutics-Announces-FDA-Advisory-Committee-Meeting-to-Review-IV-Tramadol-NDA-Tentatively-Scheduled-for-February-15-2022.html

    GLOBENEWSWIRE
    29 Nov 2021
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    Avenue Therapeutics Prices $2.6 M Underwritten Public Offering of Common Stock
    Avenue Therapeutics Prices $2.6 M Underwritten Public Offering of Common Stock

    https://www.globenewswire.com/news-release/2021/11/10/2331064/0/en/Avenue-Therapeutics-Prices-2-6-Million-Underwritten-Public-Offering-of-Common-Stock.html

    GLOBENEWSWIRE
    09 Nov 2021
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    Avenue's IV tramadol pain drug gets another negative FDA response
    Avenue's IV tramadol pain drug gets another negative FDA response

    https://www.marketwatch.com/story/avenue-therapeutics-iv-tramadol-gets-negative-fda-response-271623669087

    MARKET WATCH
    14 Jun 2021
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    W-Transcutaneous Electrical Nerve Stimulation More Effective Than Weak Opioids
    W-Transcutaneous Electrical Nerve Stimulation More Effective Than Weak Opioids

    https://ard.bmj.com/content/80/Suppl_1/364

    BMJ
    09 Jun 2021
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    Avenue Therapeutics receives Complete Response Letter from USFDA for IV tramadol
    Avenue Therapeutics receives Complete Response Letter from USFDA for IV tramadol

    https://www.business-standard.com/article/news-cm/avenue-therapeutics-receives-complete-response-letter-from-usfda-for-iv-tramadol-120101201077_1.html

    BUSINESS-STANDARD
    12 Oct 2020
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    FDA Approves NDA for QDOLO Oral Solution
    FDA Approves NDA for QDOLO Oral Solution

    https://www.americanpharmaceuticalreview.com/1315-News/568055-FDA-Approves-NDA-for-QDOLO-Oral-Solution/?catid=6262

    USA PHARMACEUTICALREVIEW
    10 Sep 2020
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    U.S. FDA Approves Athena Bioscience's NDA for QDOLO Oral Solution
    U.S. FDA Approves Athena Bioscience's NDA for QDOLO Oral Solution

    https://www.biospace.com/article/releases/u-s-fda-approves-athena-bioscience-s-new-drug-application-nda-for-qdolo-tramadol-hydrochloride-oral-solution/

    BIOSPACE
    08 Sep 2020
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    Avenue Therapeutics Announces Publications in Peer-Reviewed Journals
    Avenue Therapeutics Announces Publications in Peer-Reviewed Journals

    https://www.globenewswire.com/news-release/2020/06/05/2044292/0/en/Avenue-Therapeutics-Announces-Publications-in-Peer-Reviewed-Journals.html

    GLOBENEWSWIRE
    05 Jun 2020
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    There Is a Lack of Evidence, Transparency About Ingredients to Support Use
    There Is a Lack of Evidence, Transparency About Ingredients to Support Use

    https://www.nationalacademies.org/news/2020/05/there-is-a-lack-of-evidence-transparency-about-ingredients-to-support-use-of-compounded-topical-pain-creams-says-new-report

    NATIONNALACADEMIES
    13 May 2020
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    Enforcement Report - Week of March 4, 2020
    Enforcement Report - Week of March 4, 2020

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-4-2020-1583324392.pdf

    FDA
    04 Mar 2020
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    Avenue Therapeutics Announces New Drug Application for IV Tramadol
    Avenue Therapeutics Announces New Drug Application for IV Tramadol

    https://www.globenewswire.com/news-release/2020/02/13/1984507/0/en/Avenue-Therapeutics-Announces-New-Drug-Application-for-IV-Tramadol-Accepted-for-Review-by-FDA.html

    GLOBENEWSWIRE
    13 Feb 2020
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    Beset by lawsuits and criticism in U.S., opioid makers eye new market in India
    Beset by lawsuits and criticism in U.S., opioid makers eye new market in India

    https://www.fiercepharma.com/pharma/beset-by-lawsuits-and-criticism-u-s-opioid-makers-eye-new-market-india

    Sarah Varney FIERCE PHARMA
    31 Aug 2019
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    Major drug bust at Faridkot by FDA, CIA teams
    Major drug bust at Faridkot by FDA, CIA teams

    https://indianexpress.com/article/india/major-drug-bust-at-faridkot-by-fda-cia-teams/

    INDIANEXPRESS
    29 Aug 2019
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    Unichem Labs Generic Tramadol Hydrochloride Receives Approval in US
    Unichem Labs Generic Tramadol Hydrochloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211825

    FDA
    14 Aug 2019
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    Asclemed USA Inc Receives FDA Warning Letter
    Asclemed USA Inc Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/asclemed-usa-inc-receives-fda-warning-letter-1562147954.pdf

    FDA
    03 Jul 2019
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    POLYGEN PHARMS's generic TRAMADOL HYDROCHLORIDE Receives Approval in US
    POLYGEN PHARMS's generic TRAMADOL HYDROCHLORIDE Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206706

    FDA
    02 Jul 2019
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    RUBICON's generic TRAMADOL HYDROCHLORIDE Receives Approval in US
    RUBICON's generic TRAMADOL HYDROCHLORIDE Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208708

    FDA
    28 Jun 2019
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    Syntrix Pharmaceuticals' Positive Double-Blind Clinical Trials of Desmetramadol
    Syntrix Pharmaceuticals' Positive Double-Blind Clinical Trials of Desmetramadol

    https://www.prnewswire.com/news-releases/syntrix-pharmaceuticals-announces-publication-of-positive-double-blind-clinical-trials-showing-desmetramadol-has-the-analgesic-and-side-effect-profile-of-tramadol-without-its-metabolic-liabilities-300861610.html

    PR NEWSWIRE
    04 Jun 2019
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    PvPI releases list of 9 drugs with previously unknown AEs; list
    PvPI releases list of 9 drugs with previously unknown AEs; list

    http://www.pharmabiz.com/NewsDetails.aspx?aid=114890&sid=1

    PHARMABIZ
    27 Mar 2019
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    Cipla's subsidiary to acquire US-based Avenue Therapeutics for $ 215 million
    Cipla's subsidiary to acquire US-based Avenue Therapeutics for $ 215 million

    https://health.economictimes.indiatimes.com/news/pharma/ciplas-subsidiary-to-acquire-us-based-avenue-therapeutics-for-215-million/66607220

    ECONOMIC TIMES
    13 Nov 2018
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    Store Pills Network Receives FDA Warning Letter
    Store Pills Network Receives FDA Warning Letter

    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623286.htm

    FDA
    24 Oct 2018
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    Farma Glow Receives FDA Warning Letter
    Farma Glow Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/farma-glow-receives-fda-warning-letter-1549432879.pdf

    FDA
    24 Oct 2018
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    RxAff Receives FDA Warning Letter
    RxAff Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/rxaff-receives-fda-warning-letter-1549433080.pdf

    FDA
    24 Oct 2018
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    Osmotica Pharmaceuticals Files To Raise Capital In U.S. IPO
    Osmotica Pharmaceuticals Files To Raise Capital In U.S. IPO

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

    Donovan Jones SEEKING ALPHA
    19 Sep 2018
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    Seized painkillers turn out to be fakes
    Seized painkillers turn out to be fakes

    https://health.economictimes.indiatimes.com/news/industry/seized-painkillers-turn-out-to-be-fakes/65657011

    Raj Shekhar ECONOMIC TIMES
    04 Sep 2018
    Share Share
    PharmaMedics Receives FDA Warning Letter
    PharmaMedics Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/pharmamedics-receives-fda-warning-letter-1549433684.pdf

    FDA
    29 Aug 2018
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    PharmacyAffiliates.org Receives FDA Warning Letter
    PharmacyAffiliates.org Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/pharmacyaffiliatesorg-receives-fda-warning-letter-1549433796.pdf

    FDA
    29 Aug 2018
    Share Share
    MedInc.biz Receives FDA Warning Letter
    MedInc.biz Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/medincbiz-receives-fda-warning-letter-1549433870.pdf

    FDA
    29 Aug 2018
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    FDA takes action against 21 websites marketing unapproved opioids
    FDA takes action against 21 websites marketing unapproved opioids

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618658.htm

    FDA
    29 Aug 2018
    Share Share
    CoinRx Receives FDA Warning Letter
    CoinRx Receives FDA Warning Letter

    https://www.pharmacompass.com/pdf/news/coinrx-receives-fda-warning-letter-1549433729.pdf

    FDA
    28 Aug 2018
    Share Share
    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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    NCB busts Gurgaon-based online pharmacy for shipping illegal drugs
    NCB busts Gurgaon-based online pharmacy for shipping illegal drugs

    https://health.economictimes.indiatimes.com/news/pharma/ncb-busts-gurgaon-based-online-pharmacy-for-shipping-illegal-drugs/65271399

    ECONOMIC TIMES
    06 Aug 2018
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    Congress, Feds, FDA Take Action to Combat Opioid Crisis
    Congress, Feds, FDA Take Action to Combat Opioid Crisis

    http://www.pharmexec.com/congress-feds-fda-take-action-combat-opioid-crisis

    PHARMA EXEC
    06 Jul 2018
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    FDA Warns Korean, Australian Drugmakers, Online Opioid Sellers
    FDA Warns Korean, Australian Drugmakers, Online Opioid Sellers

    https://www.raps.org/news-and-articles/news-articles/2018/6/fda-warns-korean-australian-drugmakers-online-op?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails&_zs=VHOsL1&_zl=vjkU4

    Michael Mezher RAPS
    05 Jun 2018
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    FDA sends warning letters to nine online marketers over opioids
    FDA sends warning letters to nine online marketers over opioids

    https://www.reuters.com/article/us-fda-opioid/fda-sends-warning-letters-to-nine-online-marketers-over-opioids-idUSKCN1J12A1

    Anuron Mitra REUTERS
    05 Jun 2018
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    Another cheap, old drug is being freshened up for brand pricing in the US
    Another cheap, old drug is being freshened up for brand pricing in the US

    https://endpts.com/another-cheap-old-drug-is-being-freshened-up-for-brand-pricing-in-the-us/

    John Carroll ENDPTS
    22 May 2018
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    Govt brings 'ISIS drug' Tramadol under narcotics law regulation
    Govt brings 'ISIS drug' Tramadol under narcotics law regulation

    https://health.economictimes.indiatimes.com/news/pharma/govt-brings-isis-drug-tramadol-under-narcotics-law-regulation/63967996

    N. Srivastava ECONOMIC TIMES
    30 Apr 2018
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    Enforcement Report - Week of April 18, 2018
    Enforcement Report - Week of April 18, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-18-2018-1524029703.pdf

    FDA
    18 Apr 2018
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    NHS accused of ‘creating drug addicts’ as opioid use soars
    NHS accused of ‘creating drug addicts’ as opioid use soars

    http://www.theweek.co.uk/92343/nhs-accused-of-creating-drug-addicts-as-opioid-use-soars

    Fred Tanneau THEDWEEK
    16 Mar 2018
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    Mundipharma to market Grünenthal’s pain drug, Tramal in China
    Mundipharma to market Grünenthal’s pain drug, Tramal in China

    http://www.pharmabiz.com/NewsDetails.aspx?aid=106711&sid=2

    PHARMABIZ
    15 Jan 2018
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    Athena’s First Paracetamol + Tramadol APAP ODT Launch in Chile
    Athena’s First Paracetamol + Tramadol APAP ODT Launch in Chile

    https://athenapharmaceutiques.com/wp-content/uploads/2020/12/May-2017-para-trama.pdf

    PRESS RELEASE
    30 Oct 2017
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    FDA Warns Drugmaker Over Opioid Marketing Materials
    FDA Warns Drugmaker Over Opioid Marketing Materials

    http://www.raps.org/Regulatory-Focus/News/2017/09/05/28414/FDA-Warns-Drugmaker-Over-Opioid-Marketing-Materials/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

    Michael Mezher RAPS
    05 Sep 2017
    Share Share
    Macleod's Generic Acetaminophen; Tramadol Hydrochloride Receives Approval In US
    Macleod's Generic Acetaminophen; Tramadol Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206885

    FDA
    06 May 2017
    Share Share
    FDA Ban Codeine and Tramadol Due To it Can Cause Breathing Problems for Children
    FDA Ban Codeine and Tramadol Due To it Can Cause Breathing Problems for Children

    https://www.pharmacompass.com/pdf/news/fda-ban-codeine-and-tramadol-due-to-it-can-cause-breathing-problems-for-children-1492847186.pdf

    FDA
    22 Apr 2017
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