Application 212218
- Type
- ANDA
- Sponsor
- JUBILANT CADISTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No |
| 002 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | No | No |
| 003 | CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-710 | Clomipramine Hydrochloride | Clomipramine HCl | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |
| 59746-711 | Clomipramine Hydrochloride | Clomipramine HCl | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |
| 59746-712 | Clomipramine Hydrochloride | Clomipramine HCl | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |