HYLENEX Recombinant - Hyaluronidase Recombinant Human
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Field |
Value |
NDC Code: |
60977-319 |
Proprietary Name: |
HYLENEX Recombinant |
Suffix: |
|
Non-Proprietary Name: |
Hyaluronidase Recombinant Human |
Dosage Form: |
INJECTION, SOLUTION |
Method: |
SUBCUTANEOUS |
Original Marketing Date: |
02-12-2005 |
Category Name: |
NDA |
Application Number: |
NDA021859 |
Labeler: |
BAXTER HEALTHCARE CORPORATION |
Substance Name: |
HYALURONIDASE RECOMBINANT HUMAN |
Active Numerator Strength: |
150 |
Active Ingredient Unit: |
[USP'U]/mL |
Pharm Classes: |
Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] |
DEA Schedule: |
|