Application 210997
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 0.2MG/ML (0.2MG/ML) | No | No |
| 002 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 0.4MG/2ML (0.2MG/ML) | No | No |
| 003 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 1MG/5ML (0.2MG/ML) | No | No |
| 004 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 0.6MG/3ML (0.2MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51754-6000 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6000 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6000 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6001 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6001 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6001 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6015 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6015 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82897 | SUPPL | 2025-07-21 |
| 82886 | SUPPL | 2025-07-17 |
| 56423 | ORIG | 2018-11-13 |
| 56422 | ORIG | 2018-11-13 |
| 54888 | ORIG | 2018-07-16 |
| 54887 | ORIG | 2018-07-16 |
| 54875 | ORIG | 2018-07-12 |
| 54874 | ORIG | 2018-07-12 |