Application 090331
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LANSOPRAZOLE | LANSOPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | No | No |
| 002 | LANSOPRAZOLE | LANSOPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-2147 | Lansoprazole | Lansoprazole | Sandoz Inc | ANDA | Current |
| 0781-2147 | Lansoprazole | Lansoprazole | Sandoz Inc | ANDA | Current |
| 0781-2147 | Lansoprazole | Lansoprazole | Sandoz Inc | ANDA | Current |
| 0781-2148 | Lansoprazole | Lansoprazole | Sandoz Inc | ANDA | Current |
| 0781-2148 | Lansoprazole | Lansoprazole | Sandoz Inc | ANDA | Current |
| 0781-2148 | Lansoprazole | Lansoprazole | Sandoz Inc | ANDA | Current |
| 68788-6389 | Lansoprazole | Lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8915 | Lansoprazole | Lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |