Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Ferring International Center S.A.
481210362
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Mikart, LLC
Amring Pharmaceuticals, Inc.
Ferring International Center S.A.
030034847
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
69918-301Application Number
NDA022430Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 18, 2020Tranexamic acidActive
Code: 6T84R30KC1Class: ACTIBQuantity: 650 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT