Application 091231
- Type
- ANDA
- Sponsor
- WOCKHARDT
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 |
|---|---|---|---|---|---|
| 50436-8102 | PANTOPRAZOLE SODIUM | Pantoprazole sodium | Unit Dose Services | ANDA | Current |
| 55648-433 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-434 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 64679-433 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-433 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-433 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-434 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-434 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-434 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 68788-9557 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |