Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
OrBion Pharmaceuticals Private Limited
Alvogen Inc.
OrBion Pharmaceuticals Private Limited
854403569
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
47781-103Application Number
ANDA078998Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2017IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 150 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT