Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotex Inc.
209429182
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Apotex Corp.
Apotex Inc.
918601238
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
60505-6097Application Number
ANDA204222Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 14, 2023IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 3 mg in 3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT