Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Intas Pharmaceuticals Limited.
Accord Healthcare Inc.
725927649
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibandronate Sodium
Product Details
NDC Product Code
16729-274Application Number
ANDA206058Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 9, 2024SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 3 mg in 3 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT