Application 077619
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
| 002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 53808-1007 | Pantoprazole | Pantoprazole | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1081 | Pantoprazole | Pantoprazole | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55111-332 | Pantoprazole | Pantoprazole | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-332 | Pantoprazole | Pantoprazole | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-332 | Pantoprazole | Pantoprazole | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-333 | Pantoprazole | Pantoprazole | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-333 | Pantoprazole | Pantoprazole | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-333 | Pantoprazole | Pantoprazole | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 60760-574 | Pantoprazole | Pantoprazole | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 68071-2845 | Pantoprazole | Pantoprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2891 | Pantoprazole | Pantoprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2891 | Pantoprazole | Pantoprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |