Application 091434
- Type
- ANDA
- Sponsor
- TORRENT PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 2.5MG | No | No |
| 002 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 5MG | No | No |
| 003 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 7.5MG | No | No |
| 004 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 10MG | No | No |
| 005 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 15MG | No | No |
| 006 | OLANZAPINE | OLANZAPINE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13668-166 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-166 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-167 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-167 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-167 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-167 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-167 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-168 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-169 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-169 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-169 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-169 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-169 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-170 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-170 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-170 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-170 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-170 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-171 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-171 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-171 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-171 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-171 | OLANZAPINE | OLANZAPINE | Torrent Pharmaceuticals Limited | ANDA | Current |