FdaApplication
NDA 210997
Identifiers
- fda_app_no: NDA210997
Properties
| Property | Value |
|---|---|
| applicant_name | EXELA PHARMA SCIENCES LLC |
| application_type | NDA |
| approval_date | 2018-07-11 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GLYRX-PF | GLYCOPYRROLATE | 0.2MG/ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
| GLYRX-PF | GLYCOPYRROLATE | 0.6MG/3ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
| GLYRX-PF | GLYCOPYRROLATE | 1MG/5ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
| GLYRX-PF | GLYCOPYRROLATE | 0.4MG/2ML (0.2MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS |
4 products