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Application 021716
- Type
- BLA
- Sponsor
- AKORN INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDASE | HYALURONIDASE | INJECTABLE;INJECTION | 150 UNITS/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 17478-560 | Hydase | Hyaluronidase | Akorn, Inc. | NDA | Current |
| 17478-560 | Hydase | Hyaluronidase | Akorn, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62337 | APPL | 2020-03-25 |
| 42282 | ORIG | 2020-03-23 |
| 28450 | SUPPL | 2020-03-23 |
| 16249 | SUPPL | 2020-03-23 |
| 16248 | ORIG | 2020-03-23 |
| 6038 | ORIG | 2020-03-23 |