Application 212411
- Type
- ANDA
- Sponsor
- SINOTHERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0527-2133 | POSACONAZOLE | Posaconazole | Lannett Company Inc. | ANDA | Current |
| 0527-2133 | POSACONAZOLE | Posaconazole | Lannett Company Inc. | ANDA | Current |
| 0527-2133 | POSACONAZOLE | Posaconazole | Lannett Company Inc. | ANDA | Current |
| 0527-2133 | POSACONAZOLE | Posaconazole | Lannett Company Inc. | ANDA | Current |
| 0527-2133 | POSACONAZOLE | Posaconazole | Lannett Company Inc. | ANDA | Current |
| 16714-156 | POSACONAZOLE | Posaconazole | NorthStar RxLLC | ANDA | Current |
| 16714-156 | POSACONAZOLE | Posaconazole | NorthStar RxLLC | ANDA | Current |
| 17856-2133 | POSACONAZOLE | Posaconazole | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 60687-523 | Posaconazole | Posaconazole | American Health Packaging | ANDA | Current |
| 60687-523 | Posaconazole | Posaconazole | American Health Packaging | ANDA | Current |
| 60687-523 | Posaconazole | Posaconazole | American Health Packaging | ANDA | Current |
| 62135-429 | POSACONAZOLE | Posaconazole Delayed-Release | Chartwell RX, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60208 | ORIG | 2019-10-03 |