Application 213454
- Type
- ANDA
- Sponsor
- AET PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POSACONAZOLE | POSACONAZOLE | TABLET, DELAYED RELEASE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7149 | POSACONAZOLE | POSACONAZOLE | Major Pharmaceuticals | ANDA | Current |
| 0904-7149 | POSACONAZOLE | POSACONAZOLE | Major Pharmaceuticals | ANDA | Current |
| 0904-7149 | POSACONAZOLE | POSACONAZOLE | Major Pharmaceuticals | ANDA | Current |
| 70748-258 | POSACONAZOLE | POSACONAZOLE | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70748-258 | POSACONAZOLE | POSACONAZOLE | Lupin Pharmaceuticals, Inc. | ANDA | Current |