Product: Zemuron®(rocuronium) Injection
Company: Organon
Petition Filer: Lachman Consultants
Petition Number(s): 2021P-0784
Date of First Petition: July 23, 2021
Responding Petitions: None
Action Requested of Petition: Petitioner would like to file an ANDA for a 20 mg/2 mL (10 mg/mL) single dose prefilled syringe of rocuronium…Read more
Product: Cardizem CD®(diltiazem) Extended-release Capsules
Company: Bausch Health
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2021P-0677
Date of First Petition: July 8, 2021
Responding Petitions: None
Action Requested of Petition: Petitioner would like to file an ANDA for a 60 mg strength of diltiazem…Read more
Product: Topamax®(topiramate) Capsules
Company: Jannsen
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2021P-0674
Date of First Petition: July 8, 2021
Responding Petitions: None
Action Requested of Petition: Petitioner would like to file an ANDA for 75 mg, 100 mg, 125 mg, 150 mg, and 200 mg strengths of topiramate…Read more
