Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
918596198
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
918596198
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
70771-1085Application Number
ANDA205228Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
November 5, 2022Tranexamic acidActive
Code: 6T84R30KC1Class: ACTIBQuantity: 100 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT