Application 208768
- Type
- ANDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POSACONAZOLE | POSACONAZOLE | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-195 | Posaconazole | Posaconazole | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71885 | ORIG | 2022-08-25 |
| 54448 | ORIG | 2018-06-05 |