Application 210927
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | INJECTABLE;INJECTION | 0.2MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-543 | GLYCOPYRROLATE | glycopyrrolate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-544 | GLYCOPYRROLATE | glycopyrrolate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-639 | GLYCOPYRROLATE | glycopyrrolate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-640 | GLYCOPYRROLATE | glycopyrrolate | Solco Healthcare US, LLC | ANDA | Current |
| 71872-7208 | GLYCOPYRROLATE | glycopyrrolate | Medical Purchasing Solutions, LLC | ANDA | Current |