Elite Pharmaceuticals Inc (ELTP): jour_trader. . .the Norco ANDA was filed...

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Elite Pharmaceuticals Inc (ELTP)

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Re: jour_trader post# 299972

Saturday, 09/08/2018 4:11:30 PM

Saturday, September 08, 2018 4:11:30 PM

jour_trader. . .the Norco ANDA was filed on December 12/2016. I do agree with you though in that we should see an approval hopefully this year.

Norco was filed end of ‘17/early ‘18. I think this one is on deck and gets approved within the next next couple of months.

From the last 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 total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response."

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