Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Macleods Pharmaceuticals Limited
Macleods Pharmaceuticals Limited
676369519
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
33342-150Application Number
ANDA206887Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 2, 2022IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 150 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT