ARTHROTEC - diclofenac sodium and misoprostol
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Field |
Value |
NDC Code: |
21695-425 |
Proprietary Name: |
ARTHROTEC |
Suffix: |
|
Non-Proprietary Name: |
diclofenac sodium and misoprostol |
Dosage Form: |
TABLET, FILM COATED |
Method: |
ORAL |
Original Marketing Date: |
24-12-1997 |
Category Name: |
NDA |
Application Number: |
NDA020607 |
Labeler: |
REBEL DISTRIBUTORS CORP. |
Substance Name: |
DICLOFENAC SODIUM; MISOPROSTOL |
Active Numerator Strength: |
75; 200 |
Active Ingredient Unit: |
mg/1; ug/1 |
Pharm Classes: |
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] |
DEA Schedule: |
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