WebAPPLICATION NUMBER: 22-512 CHEMISTRY REVIEW(S) ONDQA Division Director’s Memo NDA 22-512, PRADAXA (dabigatran etexilate) Capsules 75 mg and 150 mg ... Dabigatran etexilate mesylate drug substance is a yellow-white or yellow crystalline powder. It is manufactured at 4 sites by two manufacturing processes. Two anhydrous … WebCENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 22-512/S-011 Trade Name: PRADAXA Generic Name: dabigatran etexilate mesylate Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc. Approval Date: 05/31/2012 Indications: PRADAXA is a direct thrombin inhibitor indicated …
Dabigatran - Drugs and Lactation Database (LactMed®)
WebMar 22, 2024 · The active substance in Pradaxa, dabigatran etexilate, is a ‘prodrug’ of dabigatran. This means that it is converted into dabigatran in the body. Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting). It blocks a substance called thrombin, which is central to the process of blood clotting. WebDabigatran Etexilate Mesylate API Related Products Submit Enquiry CAS Number: 872728-81-9 Therapeutic Category Anti-Coagulant API Technology Synthetic Dose Form Oral Solids Dr Reddy's Development Status Available Available Regulatory Filing USA Europe Innovator Brand (USA) Pradaxa Mechanism of Action shush face drawing
DailyMed - DABIGATRAN ETEXILATE capsule, coated pellets
WebProduct name : Dabigatran etexilate mesylate Product Number : 25260 CAS-No. : 872728-81-9 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Manufacture of substances 1.3 Details of the supplier of the safety data sheet Company : Capot Chemical Co.,Ltd. WebDABIGATRAN ETEXILATE MESYLATE; CAS Number: 872728-81-9; Linear Formula: C35H45N7O8S; find AstaTech, Inc.-ATE428009598 MSDS, related peer-reviewed … WebGet a quote of Dabigatran Etexilate Mesylate API (CAS No. 872728-81-9) ... CAS Number: 872728-81-9 Therapeutic Category. Anti-Coagulant. API Technology. … shush finger