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FDA Approval

Tranexamic Acid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Actavis Pharma, Inc.
DUNS: 119723554
Effective Date
January 5, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tranexamic acid(650 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tranexamic Acid

Product Details

NDC Product Code
0591-3720
Application Number
ANDA202093
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 5, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIHClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
Code: 6T84R30KC1Class: ACTIBQuantity: 650 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
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