MedPath
FDA Approval

TachoSil

April 29, 2022

HUMAN PRESCRIPTION DRUG LABEL

Human thrombin(2.0 [USP'U] in 1 1)
Fibrinogen human(5.5 mg in 1 1)

Products (3)

TachoSil

0338-8704

BLA125351

BLA (C73585)

TOPICAL

April 13, 2022

Code: 6K15ABL77GClass: ACTIBQuantity: 2.0 [USP'U] in 1 1
Code: N94833051KClass: ACTIBQuantity: 5.5 mg in 1 1
EQUINE COLLAGENInactive
Code: 3221SCV0LSClass: IACT
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACT
RIBOFLAVINInactive
Code: TLM2976OFRClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20YClass: IACT

TachoSil

0338-8701

BLA125351

BLA (C73585)

TOPICAL

April 13, 2022

Code: N94833051KClass: ACTIBQuantity: 5.5 mg in 1 1
Code: 6K15ABL77GClass: ACTIBQuantity: 2.0 [USP'U] in 1 1
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACT
RIBOFLAVINInactive
Code: TLM2976OFRClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20YClass: IACT
EQUINE COLLAGENInactive
Code: 3221SCV0LSClass: IACT

TachoSil

0338-8702

BLA125351

BLA (C73585)

TOPICAL

April 13, 2022

Code: 6K15ABL77GClass: ACTIBQuantity: 2.0 [USP'U] in 1 1
ALBUMIN HUMANInactive
Code: ZIF514RVZRClass: IACT
Code: N94833051KClass: ACTIBQuantity: 5.5 mg in 1 1
EQUINE COLLAGENInactive
Code: 3221SCV0LSClass: IACT
RIBOFLAVINInactive
Code: TLM2976OFRClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ARGININE HYDROCHLORIDEInactive
Code: F7LTH1E20YClass: IACT
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