Registrants (1)
Bionpharma Inc.
079637826
Manufacturing Establishments (1)
OrBion Pharmaceuticals Private Limited
Bionpharma Inc.
Bionpharma Inc.
854403569
Products (1)
IBANDRONATE SODIUM
69452-378
ANDA078998
ANDA (C73584)
ORAL
May 23, 2023
IbandronateActive
Code: J12U072QL0Class: ACTIMQuantity: 150 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WaterInactive
Code: 059QF0KO0RClass: CNTM
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT