TICAGRELOR
These highlights do not include all the information needed to use TICAGRELOR TABLETS safely and effectively. See full prescribing information for TICAGRELOR TABLETS. TICAGRELOR tablets, for oral useInitial U.S. Approval: 2011
Approved
Approval ID
5be5ef20-fc9f-4c3b-a482-83ffd8a3ab47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2024
Manufacturers
FDA
Solco Healthcare U.S., LLC
DUNS: 828343017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ticagrelor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43547-657
Application NumberANDA208599
Product Classification
M
Marketing Category
C73584
G
Generic Name
ticagrelor
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2024
FDA Product Classification
INGREDIENTS (10)
TICAGRELORActive
Quantity: 90 mg in 1 1
Code: GLH0314RVC
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT