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Alias Born | 08/29/2012 |
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Monday, September 25, 2023 6:31:50 AM
I TRIED to tell everyone that the FDA MUST respond within 30 days after they receive the filing.
NOBODY wanted to listen to me!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Everyone ACTUALLY thought it was 45-60 days and I TOLD YOU that is NOT true.
Read the FREAKING regulations!!!!!!!!!!!!!!!!!!!!!!
Elite Pharmaceuticals Files ANDA with US FDA to Market Opiate Analgesic Product
NORTHVALE, NJ / ACCESSWIRE / September 25, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company")(OTCQB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced that it filed an Abbreviated New Drug Application (ANDA) on August 17, 2023, and was accepted for review by the US Food and Drug Administration (FDA) on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics. IQVIA reported annual sales for the twelve months ending June 2023 of $720 million for the brand and generic market for this product.
BLUE LIVES MATTER.
Recent ELTP News
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