Application 207394
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
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 |
|---|---|---|---|---|---|
| 50090-5180 | Lansoprazole | Lansoprazole | A-S Medication Solutions | ANDA | Current |
| 50090-5180 | Lansoprazole | Lansoprazole | A-S Medication Solutions | ANDA | Current |
| 67877-274 | Lansoprazole | Lansoprazole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-274 | Lansoprazole | Lansoprazole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-274 | Lansoprazole | Lansoprazole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-275 | Lansoprazole | Lansoprazole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-275 | Lansoprazole | Lansoprazole | Ascend Laboratories, LLC | ANDA | Current |
| 67877-275 | Lansoprazole | Lansoprazole | Ascend Laboratories, LLC | ANDA | Current |