Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Sunshine Lake Pharma Co., Ltd.
545391443
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sunshine Lake Pharma Co., Ltd.
Oryza Pharmaceuticals, Inc.
Sunshine Lake Pharma Co., Ltd.
545391443
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ticagrelor
Product Details
NDC Product Code
72516-018Application Number
ANDA208508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 15, 2025CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TicagrelorActive
Code: GLH0314RVCClass: ACTIBQuantity: 90 mg in 1 1
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.