Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 210997
Company: EXELA PHARMA SCS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYRX-PF GLYCOPYRROLATE 0.2MG/ML (0.2MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None No No
GLYRX-PF GLYCOPYRROLATE 0.4MG/2ML (0.2MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/11/2018 ORIG-2 Approval Efficacy STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210997Orig1s000,210997Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210997Orig1s000,210997Orig2s000TOC.cfm
07/11/2018 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210997Orig1s000,210997Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210997Orig1s000,210997Orig2s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/11/2018 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf
07/11/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210997s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English