Thrombostat
Status – approvals withdrawn
Organizations involved:
Parke-Davis Div. of Warner-Lambert Co. – Manuf.; R&D; Tech.; Former
Pfizer, Inc. – Parent; Former
Cross ref.: See the Thrombin Products entry.
Description: Thrombostat was a formulation of bovine--derived Thrombin.
Nomenclature: Thrombin/W-L [BIO]; Thrombostat [TR]; thrombin [SY]
Companies.: The product was developed and formerly manufactured and marketed by the Parke-Davis Div., Warner-Lambert Co. (which later merged into Pharmacia Corp., now merged into Pfizer Inc.), CBER/FDA est. no. 0001.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19430316; first approval
Status: Product approval withdrawn between April 2005-April 2006. No longer available.
Companies involvement:
Full monograph
921 Thrombin/W-L
Nomenclature:
Thrombin/W-L [BIO]
Thrombostat [TR]
FDA Class: Biologic PLA
Year of approval (FDA) = 1943
Date of 1st FDA approval = 19430316
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
blood products
bovine materials used<!-- bovinesource -->
bovine materials used<!-- bovinesource -->
fibrinogen
plasma (bovine)
Plasma (Human)
thrombin, bovine
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
Copyright© 2020, Biotechnology Information Institute