Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210997
Company: EXELA PHARMA
Company: EXELA PHARMA
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 | Yes | Yes |
GLYRX-PF | GLYCOPYRROLATE | 0.4MG/2ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | None | Yes | Yes |
GLYRX-PF | GLYCOPYRROLATE | 1MG/5ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | None | Yes | Yes |
GLYRX-PF | GLYCOPYRROLATE | 0.6MG/3ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | None | Yes | Yes |
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 |