Registrants (1)
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments (1)
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
Products (1)
Eszopiclone
43063-795
ANDA091124
ANDA (C73584)
ORAL
September 19, 2023
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
EszopicloneActive
Code: UZX80K71OEClass: ACTIBQuantity: 3 mg in 1 1