Ambien CR Paragraph IV Certification Filed
This article was originally published in The Pink Sheet Daily
Executive Summary
The first ANDA with a Paragraph IV certification for Ambien CR was submitted Jan. 19, according to FDA's certifications list, which was updated March 17
You may also be interested in...
Sanofi Suit Triggers 30-Month Stay Of FDA Action On Barr’s Ambien CR ANDA
Sanofi-Aventis filed a patent infringement suit against Barr on April 5 over the controlled release form of zolpidem.
Sanofi Suit Triggers 30-Month Stay Of FDA Action On Barr’s Ambien CR ANDA
Sanofi-Aventis filed a patent infringement suit against Barr on April 5 over the controlled release form of zolpidem.
Ambien CR, Razadyne ER Paragraph IV Certifications Filed
The first ANDA with a Paragraph IV certification for Sanofi-Aventis' sleep aid Ambien CR 6.25 mg was filed Feb. 24, according to FDA's May 16 updated list of filings