Application 077765
- Type
- ANDA
- Sponsor
- TORRENT PHARMS
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 |
|---|---|---|---|---|---|
| 13668-004 | Sertraline hydrochloride | Sertraline hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-005 | Sertraline hydrochloride | Sertraline hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-006 | Sertraline hydrochloride | Sertraline hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |