Application 214919
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 0.6MG/3ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76045-023 | Glycopyrrolate | Glycopyrrolate | Fresenius Kabi USA, LLC | NDA | Current |
| 76045-023 | Glycopyrrolate | Glycopyrrolate | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82898 | SUPPL | 2025-07-21 |
| 82887 | SUPPL | 2025-07-17 |
| 72323 | ORIG | 2022-10-14 |
| 70806 | ORIG | 2022-04-22 |
| 70801 | ORIG | 2022-04-22 |