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    Tag: abbreviated new drug applications

    You Searched For "abbreviated new drug applications"
    Aurobindo Pharma Q2 net profit up by 5 pc to Rs 640 crore

    Aurobindo Pharma Q2 net profit up by 5 pc to Rs 640 crore

    Medical Dialogues Bureau14 Nov 2019 9:30 AM IST
    Managing director of Aurobindo Pharma N Govindarajan said We had another quarter of healthy performance where we continued to grow in the US and...
    Zydus Cadila gets USFDA nod for Colesevelam Hydrochloride tablets for lowering cholesterol

    Zydus Cadila gets USFDA nod for Colesevelam Hydrochloride tablets for lowering cholesterol

    Medical Dialogues Bureau10 Oct 2019 11:34 AM IST
    Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Colesevelam Hydrochloride tablets,...
    Cadila Healthcare posts Q4 net profit of Rs 460 crore

    Cadila Healthcare posts Q4 net profit of Rs 460 crore

    Medical Dialogues Bureau30 May 2019 9:15 AM IST
    The consolidated financial statements for the quarter and the year ended March 31, 2019, including the operations of Heinz India Pvt Ltd (HIPL) for...
    Cipla plans to file over dozen new drug applications for FY20

    Cipla plans to file over dozen new drug applications for FY20

    Garima27 May 2019 9:30 AM IST
    In another key market of South Africa, during the current fiscal year, Cipla is looking to strengthen its OTC (over-the-counter) business.New Delhi:...
    Zydus Cadila gets USFDA nod for Chlorthalidone tablets to treat high BP

    Zydus Cadila gets USFDA nod for Chlorthalidone tablets to treat high BP

    Farhat Nasim13 May 2019 10:31 AM IST
    Zydus Cadila said Chlorthalidone tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad.New Delhi: Drug...
    Zydus Cadila gets USFDA nod to market 2 generic drugs

    Zydus Cadila gets USFDA nod to market 2 generic drugs

    Medical Dialogues Bureau1 May 2019 8:05 PM IST
    New Delhi: Drug firm Zydus Cadila Tuesday said it has received the final nod from the USFDA to market generic Bosentan tablets and Trientine...
    Zydus Cadila gets USFDA nod for Phentermine Hydrochloride orally disintegrating tablets

    Zydus Cadila gets USFDA nod for Phentermine Hydrochloride orally disintegrating tablets

    Medical Dialogues Bureau26 April 2019 8:59 AM IST
    Phentermine Hydrochloride orally disintegrating tablets is used together with diet and exercise to treat obesity (overweight) in people with risk...
    Indoco Remedies: USFDA retains OAI status for Goa plant

    Indoco Remedies: USFDA retains OAI status for Goa plant

    Farhat Nasim25 April 2019 9:50 AM IST
    Indoco Remedies' spokesperson said that the move is likely to withhold approval of pending abbreviated new drug applications (ANDAs) from Goa...
    USFDA Caution: Lupin gets OAI letter for MP plant

    USFDA Caution: Lupin gets OAI letter for MP plant

    Medical Dialogues Bureau17 March 2019 9:45 AM IST
    Lupin has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility...
    Glenmark gets USFDA nod for generic version of acne treatment gel

    Glenmark gets USFDA nod for generic version of acne treatment gel

    Farhat Nasim17 March 2019 9:21 AM IST
    New Delhi: Glenmark Pharmaceuticals Friday said it has received final approval from the US health regulator for its generic version of BenzaClin gel...
    Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

    Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

    Farhat Nasim8 Feb 2019 11:40 AM IST
    Fulvestrant injection is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex injection in the same strength, it added. The Faslodex...
    Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

    Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

    Medical Dialogues Bureau24 Jan 2019 9:30 AM IST
    Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets...
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