;NDC:25208-002-02 1 in 1 CARTON 05/14/1998
2 250 mL in 1 CONTAINER; Type 0: Not a Combination Product
3 NDC:25208-002-03 1 in 1 CARTON 10/15/2016
3 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020913 05/14/1998
AGGRASTAT
tirofiban injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25208-001
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIROFIBAN HYDROCHLORIDE (UNII: 6H925F8O5J) (TIROFIBAN - UNII:GGX234SI5H) TIROFIBAN 3.75 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 2.4 mg in 15 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 40.5 mg in 15 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 120 mg in 15 mL
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25208-001-04 1 in 1 CARTON 10/15/2016
1 15 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020912 10/15/2016
LABELER - MEDICURE INTERNATIONAL INC (860240324)
REGISTRANT - MEDICURE INTERNATIONAL INC (860240324)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Baxter Healthcare Corporation 059140764 manufacture(25208-002) , analysis(25208-002) , pack(25208-002) , label(25208-002)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Cangene BioPharma, LLC 050783398 manufacture(25208-001) , analysis(25208-001) , pack(25208-001) , label(25208-001)
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