Application 022571
- Type
- NDA
- Sponsor
- MERZ PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CUVPOSA | GLYCOPYRROLATE | SOLUTION;ORAL | 1MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0259-0501 | Cuvposa | glycopyrrolate | Merz Pharmaceuticals, LLC | NDA | Current |
| 0259-0501 | Cuvposa | glycopyrrolate | Merz Pharmaceuticals, LLC | NDA | Current |
| 0259-0501 | Cuvposa | glycopyrrolate | Merz Pharmaceuticals, LLC | NDA | Current |
| 0259-0501 | Cuvposa | glycopyrrolate | Merz Pharmaceuticals, LLC | NDA | Current |
| 0259-0501 | Cuvposa | glycopyrrolate | Merz Pharmaceuticals, LLC | NDA | Current |
| 0259-0501 | Cuvposa | glycopyrrolate | Merz Pharmaceuticals, LLC | NDA | Current |
| 0259-0502 | Glycopyrrolate | Glycopyrrolate | Merz Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |