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)
ZALEPLON
43063-505
ANDA078829
ANDA (C73584)
ORAL
September 26, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ZaleplonActive
Code: S62U433RMHClass: ACTIBQuantity: 5 mg in 1 1