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OPSUMIT - macitentan

Navigation: NDC > Supplier starting with: A > ACTELION PHARMACEUTICALS US, INC.
Field Value
NDC Code: 66215-501
Proprietary Name: OPSUMIT
Suffix:
Non-Proprietary Name: macitentan
Dosage Form: TABLET, FILM COATED
Method: ORAL
Original Marketing Date: 01-10-2013
Category Name: NDA
Application Number: NDA204410
Labeler: ACTELION PHARMACEUTICALS US, INC.
Substance Name: MACITENTAN
Active Numerator Strength: 10
Active Ingredient Unit: mg/1
Pharm Classes:
DEA Schedule: