Hi there are 14-15 generic products that ACR started working on back in 2014-15. Three have had dossiers submitted to the FDA. Around this time last year ACR in a investor presentation said they are on track to submit 4 dossiers this calendar year 2020, and that within 3 years (that being around April/May 2022) they hope to have up to 10 dossiers submitted. As to how long US FDA approval takes is the unknown factor. In some cases it's 9months, others its 30months and still others its potentially years. I have no idea which drug gets which time line. On the plus side the drug in a generic has already been approved by the FDA and the whole process is supposed to be a lot quicker for and ANDA (abbreviated new drug application) than an NDA (new drug application) . this may also have slowed as since the the Covid-19 pandemic started the FDA has had its hands full with drug applications/labeling to cope with that, as well as their usual work. For me I'm focusing on ACR hopefully submitting as many ANDA applications as it can, as quick as they can. As once they have 7or more dossiers submitted it may be a takeover target for a much larger drug coy. hope that helps. Jetrodder
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Hi there are 14-15 generic products that ACR started working on...
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