↓
 

Gregory Glass

FDA Petitions

Gregory Glass
  • FDA Petitions Home
  • Editor’s Note
  • The Petition Process
  • FDA Petitions Database
    • Get Access
Home→gregoryglass

gregoryglass

Profile picture of gregoryglass

@gregoryglass

Active 22 hours, 4 minutes ago
  • Home
  • Activity
  • Profile
  • Forums
  • View

View Profile

Login

Log In

Search Forums

Latest updates

Product: Emerphed®(ephedrine sulfate) Injection
Company: Nexus Pharmaceuticals
Petition Filer: Nexus Pharmaceuticals
Petition Number(s): 2021P-0358
Date of Petition: April 8, 2021
Responding Petitions:

Issue and Implication: Whether FDA regulations regarding restrictions on compounding pharmacies to make copies of FDA approved…Read more

Profile picture of gregoryglass 21 hours, 19 minutes ago

Product: Ascor®(ascorbic acid) Injection
Company: McGuff Pharmaceuticals
Petition Filer: BPI Labs
Petition Number(s): 2021P-0345
Date of First Petition: April 1, 2021
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for an ascorbic acid injection 5000 mg/10 mL (500 mg/mL). Using the…Read more

Profile picture of gregoryglass 1 week ago

Product: Indocin®(indomethacin) Suppositories
Company: Egalet US
Petition Filer: Zydus
Petition Number(s): 2021P-0344
Date of First Petition: April 1, 2021
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for an indomethacin suppository 100mg. Using the Indocin®(indomethacin) S…Read more

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