↓
 

Gregory Glass

FDA Petitions

Gregory Glass
  • FDA Petitions Home
  • Editor’s Note
  • The Petition Process
  • FDA Petitions Database
    • Get Access
Home 1 2 >>

FDA Petitions Database

FDA Petitions Home › FDA Petitions Database

    • Forum
    • Topics
    • Posts
    • Last Post
    • Petitions (Current and Active Since January 1, 2004)
      • Product Petitions

      • Issue Petitions

      • Suitability Petitions

      • Safety Petitions

      • New Filings, Recent FDA Decisions, and Statistics
    • 376
    • 376
    • 1 week, 1 day ago

      gregoryglass

    • Archives (Closed Petitions)
      • Product Petitions Archives

      • Issue Petitions Archives

      • Suitability Petitions Archives

      • Safety Petitions Archives
    • 958
    • 958
    • 3 months, 2 weeks ago

      gregoryglass

    • Research Criteria and Technical Notes
      • About FDAPetitions.com

      • Terms and Conditions
    • 4
    • 4
    • No Topics

  •  

Login

Log In

Search Forums

Latest updates

Product: Zebeta®(bisoprolol) Tablets
Company: Teva
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2021P-0037
Date of Petition: January 11, 2021
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for two dosage strengths of Zebeta®(bisoprolol) Tablets, being the 2.5mg (…Read more

Profile picture of gregoryglass 1 week, 1 day ago

Product: Quelicin®(succinylcholine) Injection
Company: Hospira
Petition Filer: Baxter Healthcare
Petition Number(s): 2020P-2317
Date of Petition: December 22, 2020
Responding Petitions:

Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Quelicin®(succinylcholine) Injection (NDA 008845) (Quelicin P…Read more

Profile picture of gregoryglass 4 weeks ago

Product: Razadyne®(galantamine) Tablets
Company: Janssen
Petition Filer: Alpha Cognitition
Petition Number(s): 2020P-2301
Date of Petition: December 16, 2020
Responding Petitions:

Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is discontinued or unavailable on the market.

Action…Read more

Profile picture of gregoryglass 1 month ago
FDAPetitions.com™ is a trademark of Parry Ashford Inc. • ©Parry Ashford Inc. 2021
↑