ELELYSO - Taliglucerase alfa
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Field |
Value |
NDC Code: |
0069-0106 |
Proprietary Name: |
ELELYSO |
Suffix: |
|
Non-Proprietary Name: |
Taliglucerase alfa |
Dosage Form: |
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
01-05-2012 |
Category Name: |
NDA |
Application Number: |
NDA022458 |
Labeler: |
PFIZER LABORATORIES DIV PFIZER INC |
Substance Name: |
TALIGLUCERASE ALFA |
Active Numerator Strength: |
200 |
Active Ingredient Unit: |
U/5mL |
Pharm Classes: |
Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC],Glucosylceramidase [Chemical/Ingredient] |
DEA Schedule: |
|