Product: Metformin Extended-release Tablets
Company: Various
Petition Filer: Harmen Finochem
Petition Number(s): 2020P-1701
Date of Petition: July 27, 2020
Responding Petitions:
Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is in limited supply.
Action Requested by Petitioner: T…[Read more]
Product: Nipride RTU®(sodium nitroprusside) Injection
Company: Exela Pharma
Petition Filer: Cardinal Health
Petition Number(s): 2020P-1678
Date of Petition: July 20, 2020
Responding Petitions:
Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Nipriode RTU®(sodium nitroprusside) Injection 10mg/50mL (…[Read more]
Product: Dobutrex®(dobutamine) Injection
Company: Eli Lilly
Petition Filer: Cardinal Health
Petition Number(s): 2020P-1650
Date of Petition: July 10, 2020
Responding Petitions:
Action Requested by Petitioner: The petitioner would like to FDA to determine whether Dobutrex®(dobutamine) Injection 12.5mg base/mL (NDA 017820) was r…[Read more]
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