Antithrombin III Injection

Brand(s)
ATryn, Thrombate III
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Human Prescription with Highlights, Plasma Derivative
Master SPL
Grifols (2013-08-31)
Oldest Current Product
1991-12-30
License(s)
BLA
RxNORM
INJECTION\ANTITHROMBIN III
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ANTITHROMBIN ALFA
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ANTITHROMBIN ALFA

product(s) by strength(s)

antithrombin iii, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1135330604Thrombate IIIBLAGrifols1991-12-30103196b2a9f856-3ef7-8da4-920c-f738e4f1f7d7

antithrombin alfa 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1429760121ATrynBLAGtc Biotherapeutics, Inc.2009-05-06ANTITHROMBIN ALFAINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125284ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1
2673860521ATrynBLALundbeck Inc.2009-02-06ANTITHROMBIN ALFAINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125284e17ed76e-bc13-4ba2-bf1c-886fe748df4c

application(s)

#idtitleapprovedtradenamesfda division
1103196Antithrombin III (Human) Application1991-12-30Thrombate IIICBER
2125284Antithrombin (Recombinant) Application2009-02-06ATrynCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 (view SPL)Antithrombin III (Human) THROMBATE IIIotherPlasma DerivativeGrifolsMANUFACTURE2013-08-3111135330604, 135330603
2e17ed76e-bc13-4ba2-bf1c-886fe748df4c (view SPL)These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn. ATryn, Antithrombin (Recombinant) Lyophilized powder for reconstitution Initial U.S. Approval: 2009prescriptionHuman Prescription with HighlightsLundbeck Inc.ANALYSIS, MANUFACTURE2010-06-041673860521
3ecc5f10c-e89e-4757-a56a-9cfa6fd383f7 (view SPL)These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn. ATryn, Antithrombin (Recombinant) Lyophilized powder for reconstitution Initial U.S. Approval: 2009prescriptionHuman PrescriptionGtc Biotherapeutics, Inc.2013-12-011429760125
4ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1 (view SPL)These highlights do not include all the information needed to use ATryn safely and effectively. See full prescribing information for ATryn. ATryn, Antithrombin (Recombinant) Lyophilized powder for reconstitution Initial U.S. Approval: 2009prescriptionHuman PrescriptionGtc Biotherapeutics, Inc.manufacture2010-11-151429760121

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII