Application 214721
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70954-261 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Novitium Pharma LLC | ANDA | Current |