Application 212058
- Type
- ANDA
- Sponsor
- SUNGEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-963 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-963 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 70625-103 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | SunGen Pharma LLC | ANDA | Current |
| 70625-103 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Praxgen Pharmaceuticals LLC | ANDA | Current |