Application 076882
- Type
- ANDA
- Sponsor
- VIWIT PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42337-201 | Sertraline Hydrochloride | sertraline hydrochloride | Viwit Pharmaceutical Co., Ltd. | ANDA | Current |
| 42337-202 | Sertraline Hydrochloride | sertraline hydrochloride | Viwit Pharmaceutical Co., Ltd. | ANDA | Current |
| 42337-203 | Sertraline Hydrochloride | sertraline hydrochloride | Viwit Pharmaceutical Co., Ltd. | ANDA | Current |