Application 212328
- Type
- ANDA
- Sponsor
- SUNSHINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | No | No |
| 003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7895 | DULOXETINE | Duloxetine hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7896 | DULOXETINE | Duloxetine hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7897 | DULOXETINE | Duloxetine hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |