Registrants (1)
DIRECT RX
079254320
Manufacturing Establishments (1)
DIRECT RX
DIRECT RX
DIRECT RX
079254320
Products (1)
ESZOPICLONE
61919-033
ANDA202929
ANDA (C73584)
ORAL
March 29, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
EszopicloneActive
Code: UZX80K71OEClass: ACTIBQuantity: 2 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT