Registrants (1)
Bionpharma Inc.
079637826
Manufacturing Establishments (1)
Aizant Drug Research Solutions Pvt. Ltd.
Bionpharma Inc.
Bionpharma Inc.
650372951
Products (2)
Fluvoxamine Maleate
69452-183
ANDA212182
ANDA (C73584)
ORAL
October 21, 2020
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403CClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FluvoxamineActive
Code: 5LGN83G74VClass: ACTIBQuantity: 150 mg in 1 1
Fluvoxamine Maleate
69452-182
ANDA212182
ANDA (C73584)
ORAL
October 21, 2020
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403CClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FluvoxamineActive
Code: 5LGN83G74VClass: ACTIBQuantity: 100 mg in 1 1
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT