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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
Effective Date
December 7, 2023
Labeling Type
Human Prescription Drug Label
Tranexamic acid(650 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Aurobindo Pharma Limited

Aurobindo Pharma Limited

918917642

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
59651-839
Application Number
ANDA205133
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 7, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 6T84R30KC1Class: ACTIBQuantity: 650 mg in 1 1
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBUClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

INDICATIONS & USAGE SECTION

Highlight: Tranexamic acid tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. (1)

1 INDICATIONS AND USAGE

Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14)].


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