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Re: jour_trader post# 299987

Saturday, 09/08/2018 9:20:38 PM

Saturday, September 08, 2018 9:20:38 PM

Post# of 401490
jour_trader. . .I believe you are referring to the CRL that was to be responded to by the end of the year.

Was in the K that they filed. Q previous to K said they wanted to file by year end.



From the February 9/2018 10Q:

On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco ® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco® is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have totalannual US sales of approximately $700 million, according to IMS Health Data. The Company received a
CRL from the FDA in October 2017 regarding this ANDA filing with actions required to resolve the deficiencies being in process. The Company intends to submit a response to the FDA addressing the deficiencies noted in the CRL and expects such response to be submitted prior to year end.

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