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ARTHROTEC - DICLOFENAC SODIUM AND MISOPROSTOL

Navigation: NDC > Supplier starting with: S > STAT RX USA LLC
Field Value
NDC Code: 16590-024
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: STAT RX USA LLC
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: