FDA.reportPublic FDA data

Autoplex, Feiba Nf, Feiba Vh Purple Book BLA 101447

BLA number
101447
Proprietary names
Autoplex, Feiba Nf, Feiba Vh
Proper names
Anti-Inhibitor Coagulant Complex
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
First observed release
2020-08-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Autoplex, Feiba Nf, Feiba VhAnti-Inhibitor Coagulant Complex351(a)1000IUFor InjectionIntravenousBottleDiscLicensed1979-12-21
002Autoplex, Feiba Nf, Feiba VhAnti-Inhibitor Coagulant Complex351(a)500IUFor InjectionIntravenousBottleDiscLicensed1979-12-21
003Autoplex, Feiba Nf, Feiba VhAnti-Inhibitor Coagulant Complex351(a)1000UFor InjectionIntravenousSingle-Dose VialRxLicensed2000-07-31
004Autoplex, Feiba Nf, Feiba VhAnti-Inhibitor Coagulant Complex351(a)500UFor InjectionIntravenousBottleRxLicensed2000-07-31
005Autoplex, Feiba Nf, Feiba VhAnti-Inhibitor Coagulant Complex351(a)2500UFor InjectionIntravenousSingle-Dose VialRxLicensed2005-08-11

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2023-05-01U001Autoplex, Feiba Nf, Feiba Vh351(a)DiscTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U002Autoplex, Feiba Nf, Feiba Vh351(a)DiscTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U003Autoplex, Feiba Nf, Feiba Vh351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U004Autoplex, Feiba Nf, Feiba Vh351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2023-05-01U005Autoplex, Feiba Nf, Feiba Vh351(a)RxTakeda Pharmaceuticals U.S.A., Inc.
2021-09-01U001Autoplex, Feiba Nf, Feiba Vh351(a)DiscBaxalta US Inc.
2021-09-01U002Autoplex, Feiba Nf, Feiba Vh351(a)DiscBaxalta US Inc.
2021-09-01U003Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2021-09-01U004Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2021-09-01U005Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2021-05-01U001Autoplex, Feiba Nf, Feiba Vh351(a)DiscBaxalta US Inc.
2021-05-01U002Autoplex, Feiba Nf, Feiba Vh351(a)DiscBaxalta US Inc.
2021-05-01U003Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2021-05-01U004Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2021-05-01U005Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2020-08-01R001Autoplex, Feiba Nf, Feiba Vh351(a)DiscBaxalta US Inc.
2020-08-01R002Autoplex, Feiba Nf, Feiba Vh351(a)DiscBaxalta US Inc.
2020-08-01R003Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2020-08-01R004Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.
2020-08-01R005Autoplex, Feiba Nf, Feiba Vh351(a)RxBaxalta US Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-08-01001Autoplex, Feiba Nf, Feiba Vh351(a)DiscLicensed1979-12-21
2020-08-01002Autoplex, Feiba Nf, Feiba Vh351(a)DiscLicensed1979-12-21
2020-08-01003Autoplex, Feiba Nf, Feiba Vh351(a)RxLicensed2000-07-31
2020-08-01004Autoplex, Feiba Nf, Feiba Vh351(a)RxLicensed2000-07-31
2020-08-01005Autoplex, Feiba Nf, Feiba Vh351(a)RxLicensed2005-08-11