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    Levothyroxine Sodium

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    • TABLET;ORAL - 0.0125MG;0.0031MG
    • TABLET;ORAL - 0.025MG;0.0063MG
    • TABLET;ORAL - 0.05MG;0.0125MG
    • TABLET;ORAL - 0.15MG;0.0375MG
    • TABLET;ORAL - 0.1MG;0.025MG
    • POWDER;INTRAVENOUS - 100MCG/VIAL
    • POWDER;INTRAVENOUS - 200MCG/VIAL
    • POWDER;INTRAVENOUS - 500MCG/VIAL
    • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
    • CAPSULE;ORAL - 0.013MG
    • CAPSULE;ORAL - 0.025MG
    • CAPSULE;ORAL - 0.0375MG
    • CAPSULE;ORAL - 0.044MG
    • CAPSULE;ORAL - 0.05MG
    • CAPSULE;ORAL - 0.0625MG
    • CAPSULE;ORAL - 0.075MG
    • CAPSULE;ORAL - 0.088MG
    • CAPSULE;ORAL - 0.112MG
    • CAPSULE;ORAL - 0.125MG
    • CAPSULE;ORAL - 0.137MG
    • CAPSULE;ORAL - 0.15MG
    • CAPSULE;ORAL - 0.175MG
    • CAPSULE;ORAL - 0.1MG
    • CAPSULE;ORAL - 0.2MG
    Full View ScreenFull Screen View
    Food And Drug Administration Grants Two New Label Changes To Tirosint
    Food And Drug Administration Grants Two New Label Changes To Tirosint

    https://www.businesswire.com/news/home/20231204748430/en

    BUSINESSWIRE
    05 Dec 2023
    Share Share
    Enforcement Report - Week of November 15, 2023
    Enforcement Report - Week of November 15, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-15-2023-17266.pdf

    FDA
    15 Nov 2023
    Share Share
    Zydus Lifesciences gets USFDA nod to market generic drug
    Zydus Lifesciences gets USFDA nod to market generic drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-lifesciences-gets-usfda-nod-to-market-generic-drug/articleshow/99054057.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

    ECONOMIC TIMES
    28 Mar 2023
    Share Share
    Enforcement Report - Week of March 8, 2023
    Enforcement Report - Week of March 8, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-8-2023-15780.pdf

    FDA
    08 Mar 2023
    Share Share
    Enforcement Report - Week of March 1, 2023
    Enforcement Report - Week of March 1, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-1-2023-82562.pdf

    FDA
    01 Mar 2023
    Share Share
    FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Oral Solution
    FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Oral Solution

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-levothyroxine-sodium-oral-solution-46757.pdf

    FDA
    23 Feb 2023
    Share Share
    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
    Share Share
    IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency
    IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium

    FDA
    01 Feb 2023
    Share Share
    Ascent's Generic Levothyroxine Sodium Receives Approval in the U.S.
    Ascent's Generic Levothyroxine Sodium Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215259

    FDA
    18 Jan 2023
    Share Share
    Macleods' Generic Levothyroxine Sodium Receives Approval in the U.S.
    Macleods' Generic Levothyroxine Sodium Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211417

    FDA
    21 Dec 2022
    Share Share
    Xeris taking subcutaneous challenger to AbbVie drug into phase 2
    Xeris taking subcutaneous challenger to AbbVie drug into phase 2

    https://www.fiercepharma.com/pharma/xeris-gets-green-light-take-subcutaneous-challenger-abbvie-drug-phase-2

    Nick Paul Taylor FIERCEPHARMA
    20 Dec 2022
    Share Share
    Xeris Announces Plans for PII Study for Investigational SC Levothyroxine
    Xeris Announces Plans for PII Study for Investigational SC Levothyroxine

    https://www.businesswire.com/news/home/20221215005134/en

    BUSINESSWIRE
    15 Dec 2022
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    FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Capsules
    FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Capsules

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-levothyroxine-sodium-capsules-53428.pdf

    FDA
    14 Dec 2022
    Share Share
    FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Oral Solution
    FDA Confirms Paragraph IV Patent Litigation for Levothyroxine Sodium Oral Solution

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-levothyroxine-sodium-oral-solution-98427.pdf

    FDA
    14 Dec 2022
    Share Share
    French drug agency says under investigation over Merck's Levothyrox
    French drug agency says under investigation over Merck's Levothyrox

    https://www.reuters.com/business/healthcare-pharmaceuticals/french-drug-agency-says-under-investigation-over-thyroid-drug-2022-12-06/

    REUTERS
    07 Dec 2022
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    Zydus' Generic Levothyroxine Sodium Receives Approval in the U.S.
    Zydus' Generic Levothyroxine Sodium Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217066

    FDA
    25 Nov 2022
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    Xeris Announces Positive PI Data of Investigational SC Levothyroxine
    Xeris Announces Positive PI Data of Investigational SC Levothyroxine

    https://www.businesswire.com/news/home/20221020005248/en

    BUSINESSWIRE
    20 Oct 2022
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    FDA Confirms Paragraph IV Patent Challenge of Levothyroxine Sodium
    FDA Confirms Paragraph IV Patent Challenge of Levothyroxine Sodium

    https://www.fda.gov/media/133240/download

    FDA
    25 Jan 2022
    Share Share
    New Study Confirms That A Commonly Used Acid-Reducing Drug Does Not Interfere
    New Study Confirms That A Commonly Used Acid-Reducing Drug Does Not Interfere

    https://www.prnewswire.com/news-releases/new-study-confirms-that-a-commonly-used-acid-reducing-drug-does-not-interfere-with-the-absorption-of-a-novel-liquid-levothyroxine-formulation-301390136.html

    PRNEWSWIRE
    04 Oct 2021
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    Pharmacokinetic Study Confirming the Bioequivalence of a Novel Oral Solof
    Pharmacokinetic Study Confirming the Bioequivalence of a Novel Oral Solof

    https://www.prnewswire.com/news-releases/pharmacokinetic-study-confirming-the-bioequivalence-of-a-novel-oral-solution-of-levothyroxine-thyquidity-to-synthroid-presented-at-the-90th-annual-meeting-of-the-american-thyroid-association-301389437.html

    PRNEWSWIRE
    01 Oct 2021
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    MHRA Class 2 Medicines Recall: Levothyroxine 50mcg tablets
    MHRA Class 2 Medicines Recall: Levothyroxine 50mcg tablets

    https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-accord-uk-ltd-trading-style-northstar-levothyroxine-tablets-bp-50-micrograms-el-21-a-slash-23

    MHRA
    27 Sep 2021
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    Xeris Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)
    Xeris Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)

    https://www.businesswire.com/news/home/20210901005212/en

    BUSINESSWIRE
    01 Sep 2021
    Share Share
    Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement
    Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement

    https://www.fda.gov/consumers/consumer-updates/older-therapies-arent-necessarily-better-thyroid-hormone-replacement

    FDA
    14 Jun 2021
    Share Share
    New Study Confirms the Stability and Potency of a Novel Formulation
    New Study Confirms the Stability and Potency of a Novel Formulation

    https://www.prnewswire.com/news-releases/new-study-confirms-the-stability-and-potency-of-a-novel-formulation-of-liquid-levothyroxine-301280724.html

    PRNEWSWIRE
    30 Apr 2021
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    New Study Confirms the Stability and Potency of a Novel Formulation
    New Study Confirms the Stability and Potency of a Novel Formulation

    https://www.prnewswire.com/news-releases/new-study-confirms-the-stability-and-potency-of-a-novel-formulation-of-liquid-levothyroxine-301280724.html

    PRNEWSWIRE
    30 Apr 2021
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    Combination thyroid hormone therapies treat hypothyroidism levothyroxine
    Combination thyroid hormone therapies treat hypothyroidism levothyroxine

    https://www.eurekalert.org/pub_releases/2021-03/tes-cth031621.php#:~:text=Results%20of%20their%20new%20randomized,with%20levothyroxine%20alone%2C%20researchers%20say.

    EUREKALERT
    22 Mar 2021
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    Vertice launches THYQUIDITY™ (levothyroxine sodium) Oral Solution
    Vertice launches THYQUIDITY™ (levothyroxine sodium) Oral Solution

    https://www.prnewswire.com/news-releases/vertice-launches-thyquidity-levothyroxine-sodium-oral-solution-301233874.html

    PRNEWSWIRE
    24 Feb 2021
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    Teva Pharms USA`s Generic Levothyroxine Sodium Receives Approval In US
    Teva Pharms USA`s Generic Levothyroxine Sodium Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213256

    FDA
    11 Jan 2021
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    MannKind and Vertice to Co-Promote Thyquidity™ (levothyroxine sodium)
    MannKind and Vertice to Co-Promote Thyquidity™ (levothyroxine sodium)

    https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-and-vertice-co-promote-thyquiditytm-levothyroxine

    PRESS RELEASE
    17 Dec 2020
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    MannKind and Vertice to Co-Promote Thyquidity™ (levothyroxine sodium)
    MannKind and Vertice to Co-Promote Thyquidity™ (levothyroxine sodium)

    https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-and-vertice-co-promote-thyquiditytm-levothyroxine

    MANNKINDCORP
    17 Dec 2020
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    Lannett Launches Authorized Generic of Tirosint® (Levothyroxine Sodium Capsules)
    Lannett Launches Authorized Generic of Tirosint® (Levothyroxine Sodium Capsules)

    https://www.prnewswire.com/news-releases/lannett-launches-authorized-generic-of-tirosint-levothyroxine-sodium-capsules-301165364.html

    PRNEWSWIRE
    03 Nov 2020
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    Good real-world outcomes for generic levothyroxine, despite narrow index
    Good real-world outcomes for generic levothyroxine, despite narrow index

    https://www.raps.org/news-and-articles/news-articles/2020/10/good-real-world-outcomes-for-generic-levothyroxine

    Mary Ellen Schneider RAPS
    09 Oct 2020
    Share Share
    Enforcement Report - Week of September 23, 2020
    Enforcement Report - Week of September 23, 2020

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-23-2020-1600837535.pdf

    FDA
    23 Sep 2020
    Share Share
    Acella Pharmaceuticals, LLC Issues Recall NP Thyroid®15 & 120 Due to Sub Potency
    Acella Pharmaceuticals, LLC Issues Recall NP Thyroid®15 & 120 Due to Sub Potency

    https://www.pharmacompass.com/pdf/news/acella-pharmaceuticals-llc-issues-recall-np-thyroid15-120-due-to-sub-potency-1600842962.pdf

    FDA
    19 Sep 2020
    Share Share
    Lannett Announces Launch Of FDA Approved Levothyroxine Tablets
    Lannett Announces Launch Of FDA Approved Levothyroxine Tablets

    http://www.pharmabiz.com/NewsDetails.aspx?aid=130125&sid=2

    PHARMABIZ
    03 Aug 2020
    Share Share
    Lannett & Cediprof Announce Distribution Agreement For An Approved Levothyroxine
    Lannett & Cediprof Announce Distribution Agreement For An Approved Levothyroxine

    https://www.prnewswire.com/news-releases/lannett-and-cediprof-announce-exclusive-distribution-agreement-for-an-approved-levothyroxine-301094577.html

    PRNEWSWIRE
    16 Jul 2020
    Share Share
    Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms
    Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms

    https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-ltd-levothyroxine-100micrograms-5ml-oral-solution-el-20-a-04

    GOVUK
    30 Jan 2020
    Share Share
    Lupin receives US FDA marketing approval for levothyroxine sodium tablets
    Lupin receives US FDA marketing approval for levothyroxine sodium tablets

    http://www.pharmabiz.com/NewsDetails.aspx?aid=119114&sid=2

    PHARMABIZ
    02 Nov 2019
    Share Share
    FDA Confirms Paragraph IV Patent Challenge of Tirosint 21924 (Levothyroxine Sodium) Capsules 88 mcg, 100 mcg and 125 mcg
    FDA Confirms Paragraph IV Patent Challenge of Tirosint 21924 (Levothyroxine Sodium) Capsules 88 mcg, 100 mcg and 125 mcg

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-tirosint-21924-levothyroxine-sodium-capsules-88-mcg-100-mcg-and-125-mcg-1569474753.pdf

    FDA
    26 Sep 2019
    Share Share
    Lannett Enters Into Advisory Services Agreement With Strategic Alliance Partner
    Lannett Enters Into Advisory Services Agreement With Strategic Alliance Partner

    https://www.prnewswire.com/news-releases/lannett-enters-into-advisory-services-agreement-with-strategic-alliance-partner-300907202.html

    PR NEWSWIRE
    27 Aug 2019
    Share Share
    Copycats wanted: Pfizer, AZ and more under threat as China solicits generics
    Copycats wanted: Pfizer, AZ and more under threat as China solicits generics

    https://www.fiercepharma.com/pharma-asia/foreign-drugmakers-under-threat-as-china-rolls-out-drug-list-to-boost-generic

    Angus Liu FIERCE PHARMA
    21 Jun 2019
    Share Share
    Lupin launches Levothyroxine Sodium tablets in US
    Lupin launches Levothyroxine Sodium tablets in US

    https://health.economictimes.indiatimes.com/news/pharma/lupin-launches-levothyroxine-sodium-tablets-in-us/68520116

    ECONOMIC TIMES
    22 Mar 2019
    Share Share
    Amneal Pharm's Generic Levothyroxine Sodium Receives Approval in US
    Amneal Pharm's Generic Levothyroxine Sodium Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210831

    FDA
    23 Feb 2019
    Share Share
    Enforcement Report - Week of December 26, 2018
    Enforcement Report - Week of December 26, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-26-2018-1545811500.pdf

    FDA
    26 Dec 2018
    Share Share
    Maia Pharms' Generic Levothyroxine Sodium Receives Approval in US
    Maia Pharms' Generic Levothyroxine Sodium Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208749

    FDA
    21 Dec 2018
    Share Share
    Enforcement Report - Week of December 19, 2018
    Enforcement Report - Week of December 19, 2018

    https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11192018103541

    FDA
    19 Dec 2018
    Share Share
    Foothills Professional Pharmacy Receives FDA Form 483
    Foothills Professional Pharmacy Receives FDA Form 483

    https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm626335.pdf

    FDA
    22 Nov 2018
    Share Share
    Enforcement Report - Week of October 24, 2018
    Enforcement Report - Week of October 24, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-24-2018-1540357479.pdf

    FDA
    24 Oct 2018
    Share Share
    Recipharm Ltd. Fails EDQM Inspection
    Recipharm Ltd. Fails EDQM Inspection

    https://www.pharmacompass.com/pdf/news/recipharm-ltd-fails-edqm-inspection-1540034321.pdf

    EDQM
    20 Oct 2018
    Share Share
    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
    Share Share
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