Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Prinston Pharmaceutical Inc.
967289799
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zhejiang Huahai Pharmaceutical Co., LTD
Solco Healthcare U.S., LLC
Prinston Pharmaceutical Inc.
530732460
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
43547-657Application Number
ANDA208599Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 23, 2024TicagrelorActive
Code: GLH0314RVCClass: ACTIBQuantity: 90 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT