WeeZuhl most definitely correct in my experience also as to what you have posted. Typically the FDA reviews the submitted ANDA on a preliminary basis as well as the GMP facilities Inspections where (1)the APIs will be received, (2) The GMP facilities where the ANDA will be manufactured, (3) the GMP facilities from where the finished ANDA will be stored and shipped from as well as (4) $ELTP SOPs for the details.
In $ELTP's Percocet case the FDA report was for "A MINOR AMENDMENT"
Elite Pharmaceuticals, Inc. ("Elite" or the “Company") received a Complete Response (CR) from the U.S. Food & Drug Administration (FDA) for its Percocet generic ANDA application. The FDA stated that the response to “the CR letter will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR.” Elite intends to submit a “MINOR AMENDMENT” shortly to address the deficiencies listed. The Percocet generic ANDA submission was received for review by the FDA in November 2016.
Percocet is a oxycodone hydrochloride with acetaminophen combination. Since $ELTP is already receiving Oxycodone it could be that The MINOR AMENDMENT, is possibly related to the API acetaminophen handling and storage, which would be new for $ELTP.
The MINOR AMENDMENT IMO should all be corrected shortly and another FDA Inspection will take place at that time. IMO a 2 -3 month duration is probably the maximum delay for the Percocet approval.
Market Data 
Markets 
AI
