MedPath
FDA Approval

ESZOPICLONE

November 7, 2017

HUMAN PRESCRIPTION DRUG LABEL

Eszopiclone(3 mg in 1 1)

Manufacturing Establishments (1)

Unit Dose Services

Unit Dose Services

831995316

Products (2)

ESZOPICLONE

50436-0322

ANDA091113

ANDA (C73584)

ORAL

July 24, 2017

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
Code: UZX80K71OEClass: ACTIBQuantity: 3 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

ESZOPICLONE

50436-0320

ANDA091113

ANDA (C73584)

ORAL

July 24, 2017

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: UZX80K71OEClass: ACTIBQuantity: 1 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
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