Application 203957
- Type
- ANDA
- Sponsor
- AJANTA PHARMA 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 |
|---|---|---|---|---|---|
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-019 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |
| 27241-020 | Lansoprazole | Lansoprazole | Ajanta Pharma Limited | ANDA | Current |