MedPath
FDA Approval

ESZOPICLONE

May 24, 2023

HUMAN PRESCRIPTION DRUG LABEL

Eszopiclone(1 mg in 1 1)

Registrants (1)

Manufacturing Establishments (1)

Preferred Pharmaceuticals, Inc.

Preferred Pharmaceuticals, Inc.

Preferred Pharmaceuticals, Inc.

791119022

Products (1)

ESZOPICLONE

68788-7667

ANDA208451

ANDA (C73584)

ORAL

May 24, 2023

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: UZX80K71OEClass: ACTIBQuantity: 1 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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