Pentasa - mesalamine
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Field |
Value |
NDC Code: |
54092-191 |
Proprietary Name: |
Pentasa |
Suffix: |
|
Non-Proprietary Name: |
mesalamine |
Dosage Form: |
CAPSULE |
Method: |
ORAL |
Original Marketing Date: |
08-07-2004 |
Category Name: |
NDA |
Application Number: |
NDA020049 |
Labeler: |
SHIRE US MANUFACTURING INC. |
Substance Name: |
MESALAMINE |
Active Numerator Strength: |
500 |
Active Ingredient Unit: |
mg/1 |
Pharm Classes: |
Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |
DEA Schedule: |
|