Kuvan - Sapropterin dihydrochloride
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Field |
Value |
NDC Code: |
68135-300 |
Proprietary Name: |
Kuvan |
Suffix: |
|
Non-Proprietary Name: |
Sapropterin dihydrochloride |
Dosage Form: |
TABLET |
Method: |
ORAL |
Original Marketing Date: |
14-12-2007 |
Category Name: |
NDA |
Application Number: |
NDA022181 |
Labeler: |
BIOMARIN PHARMACEUTICAL INC. |
Substance Name: |
SAPROPTERIN DIHYDROCHLORIDE |
Active Numerator Strength: |
100 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
|
DEA Schedule: |
|