Going through the FDA's list of ANDA approvals I compared ACL's...

Going through the FDA's list of ANDA approvals I compared ACL's ANDA application number (91316) to the last 100 ANDAs that have been approved by the FDA.

The results were that 73 ANDAs had approval numbers before ACL's application (ie they were lodged before ACL's application) and 27 were ANDA numbers indicating applications lodged after ACL's application. The last 100 ANDA's approved cover approximately two months.

For the last 50 ANDAs a similar percentage appeared, with approximately 70% pre-ACL application numbers and thus 30% post-ACL application numbers.

So it appears that ACL's application is not overdue by any means and if, as indicated, the pre-approval inspection has been ticked off, then it really is just a matter of wait and see.