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    Tag: usfda

    You Searched For "usfda"
    Zydus gets USFDA nod for Lamotrigine Extended-Release Tablets for seizures

    Zydus gets USFDA nod for Lamotrigine Extended-Release Tablets for seizures

    Medical Dialogues Bureau3 April 2020 1:32 PM IST
    Ahmedabad: Zydus Cadila has received final approval from the USFDA to market Lamotrigine Extended-Release Tablets USP in the strengths of 25 mg, 50...
    Jubilant gets USFDA EIR for its Solid Dosage facility at Salisbury, Maryland USA

    Jubilant gets USFDA EIR for its Solid Dosage facility at Salisbury, Maryland USA

    Medical Dialogues Bureau2 April 2020 2:18 PM IST
    Noida: Jubilant Life Sciences Limited, an integrated global Pharmaceutical and Life Sciences Company, has announced that Jubilant Pharma Limited, a...
    Biocon gets USFDA EIR with VAI Classification for its Malaysian Insulin Manufacturing Facility

    Biocon gets USFDA EIR with VAI Classification for its Malaysian Insulin Manufacturing Facility

    Medical Dialogues Bureau1 April 2020 12:44 PM IST
    Bengaluru: Biocon Sdn Bhd, a subsidiary of Biocon Limited has announced that it has received the Establishment Inspection Report (EIR) from the U.S....
    Lilly gets USFDA nod for Taltz(ixekizumab) for Pediatric Patients with Moderate to Severe Plaque Psoriasis

    Lilly gets USFDA nod for Taltz(ixekizumab) for Pediatric Patients with Moderate to Severe Plaque Psoriasis

    Medical Dialogues Bureau1 April 2020 12:30 PM IST
    Indianapolis: Eli Lilly and Company have announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License...
    Strides receives USFDA EIR for KRS Gardens, Bangalore facility

    Strides receives USFDA EIR for KRS Gardens, Bangalore facility

    Medical Dialogues Bureau31 March 2020 1:30 PM IST
    Bangalore: Strides Pharma Science Limited has announced that it has received the Establishment Inspection Report (EIR) for the inspection conducted by...
    Zydus gets USFDA tentative nod for  Carbidopa, Levodopa Extended-Release Capsules

    Zydus gets USFDA tentative nod for Carbidopa, Levodopa Extended-Release Capsules

    Medical Dialogues Bureau31 March 2020 1:30 PM IST
    Ahmedabad: Zydus Cadila has received tentative approval from the USFDA to market Carbidopa and Levodopa Extended-Release Capsules in the strengths of...
    South Korean coronavirus test kit makers win USFDA pre-approval

    South Korean coronavirus test kit makers win USFDA pre-approval

    Medical Dialogues Bureau30 March 2020 3:46 PM IST
    Seoul: Three Korean coronavirus test-kit makers have won preliminary approval from the U.S. Food and Drug Administration (FDA), paving the way for...
    Lupin gets USFDA EIR for Inhalation Research Center, Florida

    Lupin gets USFDA EIR for Inhalation Research Center, Florida

    Medical Dialogues Bureau30 March 2020 3:04 PM IST
    Coral Springs & Mumbai: Pharma major Lupin Limited (Lupin) has announced the receipt of the Establishment Inspection Report (EIR) from the U.S....
    Sun Pharma: USFDA classifies Halol facility as Official Action Indicated

    Sun Pharma: USFDA classifies Halol facility as Official Action Indicated

    Medical Dialogues Bureau30 March 2020 1:18 PM IST
    Mumbai: Sun Pharma has announced that the company has received communication from the USFDA indicating that the Halol facility has been classified as...
    USFDA approves Pfizer supplemental New Drug Application for EUCRISA (crisaborole) ointment for children with eczema

    USFDA approves Pfizer supplemental New Drug Application for EUCRISA (crisaborole) ointment for children with eczema

    Medical Dialogues Bureau29 March 2020 11:27 AM IST
    AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects
    With USFDA nod Abbott set to launch its point of care 5 mins coronavirus test-ID NOW COVID-19

    With USFDA nod Abbott set to launch its point of care 5 mins coronavirus test-ID NOW COVID-19

    Medical Dialogues Bureau28 March 2020 12:09 PM IST
    Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID...
    Genentech,BARDA gets USFDA nod for Actemra Clinical Trial in COVID-19 patients

    Genentech,BARDA gets USFDA nod for Actemra Clinical Trial in COVID-19 patients

    Medical Dialogues Bureau28 March 2020 10:15 AM IST
    US: Genentech, a member of the Roche Group has announced the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind,...
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