Application 212156
- Type
- NDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MICAFUNGIN | MICAFUNGIN SODIUM | INJECTABLE;INTRAVENOUS | 50MG | No | No |
| 002 | MICAFUNGIN | MICAFUNGIN SODIUM | INJECTABLE;INTRAVENOUS | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-229 | Micafungin | Micafungin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-229 | Micafungin | Micafungin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-230 | Micafungin | Micafungin | Par Pharmaceutical, Inc. | NDA | Current |
| 42023-230 | Micafungin | Micafungin | Par Pharmaceutical, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69653 | ORIG | 2021-12-20 |
| 69457 | ORIG | 2021-12-03 |
| 67841 | ORIG | 2021-06-17 |