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    Tag: USFDA

    You Searched For "USFDA"
    SMS Pharma updates against USFDA statement on Ranitidine

    SMS Pharma updates against USFDA statement on Ranitidine

    Medical Dialogues Bureau13 April 2020 9:01 AM GMT
    India: Through a recent release with the exchanges, SMS Pharma has provided update against USFDA statement on RanitidineSMS Pharma is one of the...
    Lupin gets USFDA EIR for Nagpur Facility

    Lupin gets USFDA EIR for Nagpur Facility

    Medical Dialogues Bureau13 April 2020 5:32 AM GMT
    Mumbai: Lupin Limited has announced the receipt of the Establishment Inspection Report (EIR) after the closure of the U.S. FDA inspection of its...
    Zydus gets USFDA tentative nod for Empagliflozin Tablets

    Zydus gets USFDA tentative nod for Empagliflozin Tablets

    Medical Dialogues Bureau11 April 2020 6:47 AM GMT
    Ahmedabad: Zydus Cadila has received tentative approval from the USFDA to market Empagliflozin Tablets, in the strengths of 10 mg and 25 mg (US RLD:...
    Aurobindo Pharma gets USFDA nod for Fluoxetine Tablets

    Aurobindo Pharma gets USFDA nod for Fluoxetine Tablets

    Medical Dialogues Bureau10 April 2020 7:30 AM GMT
    Hyderabad: Aurobindo Pharma Limited has announced that the Company has received the final approval from the US Food & Drug Administration (USFDA)...
    Cipla gets USFDA final approval for generic version of Proventil HFA Inhalation Aerosol

    Cipla gets USFDA final approval for generic version of Proventil HFA Inhalation Aerosol

    Medical Dialogues Bureau10 April 2020 4:30 AM GMT
    Mumbai: Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate...
    Zydus gets USFDA final approval for Imatinib Mesylate Tablets

    Zydus gets USFDA final approval for Imatinib Mesylate Tablets

    Medical Dialogues Bureau9 April 2020 7:31 AM GMT
    Ahmedabad: Zydus Cadila has received final approval from the USFDA to market Imatinib Mesylate Tablets, 100 mg and 400 mg. (US RLD: Gleevec®...
    Merck KEYTRUDA gets USFDA priority review for its Second Application

    Merck KEYTRUDA gets USFDA priority review for its Second Application

    Medical Dialogues Bureau9 April 2020 3:30 AM GMT
    Kenilworth: Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted and...
    Zydus gets USFDA final approval for Perphenazine Tablets USP

    Zydus gets USFDA final approval for Perphenazine Tablets USP

    Medical Dialogues Bureau8 April 2020 7:26 AM GMT
    Ahmedabad: Zydus Cadila has received final approval from the USFDA to market Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg. (US RLD: Trilafon®...
    Lupin launches Mycophenolic Acid Delayed-Release Tablets USP

    Lupin launches Mycophenolic Acid Delayed-Release Tablets USP

    Medical Dialogues Bureau7 April 2020 7:42 AM GMT
    Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced the launch of Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg....
    USFDA Requests Removal of All Ranitidine Products (Zantac) from the Market

    USFDA Requests Removal of All Ranitidine Products (Zantac) from the Market

    Medical Dialogues Bureau6 April 2020 3:45 AM GMT
    The U.S. Food and Drug Administration has announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine...
    Bristol Myers Squibb, bluebird bio announce submission of BLA for Myeloma Drug to USFDA

    Bristol Myers Squibb, bluebird bio announce submission of BLA for Myeloma Drug to USFDA

    Medical Dialogues Bureau4 April 2020 8:39 AM GMT
    BCMA is a protein that is nearly universally expressed on cancer cells in multiple myeloma, making it an important potential target for the treatment...
    Lupin gets USFDA EIR for Aurangabad Facility

    Lupin gets USFDA EIR for Aurangabad Facility

    Medical Dialogues Bureau4 April 2020 8:08 AM GMT
    Mumbai: Pharma major Lupin Limited (Lupin) has announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its...
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