Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AVET LIFESCIENCES PRIVATE LIMITED
853181664
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Emcure Pharmaceuticals Limited
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
AVET LIFESCIENCES PRIVATE LIMITED
675467924
GLAND PHARMA LIMITED
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
AVET LIFESCIENCES PRIVATE LIMITED
918601238
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
23155-524Application Number
ANDA203521Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 4, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
Tranexamic acidActive
Code: 6T84R30KC1Class: ACTIBQuantity: 1 g in 10 mL