MedPath
FDA Approval

Vivlodex

Egalet US Inc. (DUNS: 079581441)

April 30, 2021

HUMAN PRESCRIPTION DRUG LABEL

Meloxicam(10 mg in 1 1)

Products (2)

Vivlodex

69344-206

NDA207233

NDA (C73594)

ORAL

April 11, 2019

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 10 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT

Vivlodex

69344-205

NDA207233

NDA (C73594)

ORAL

April 11, 2019

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MeloxicamActive
Code: VG2QF83CGLClass: ACTIBQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
PIGMENT RED 5Inactive
Code: 91OZU993LXClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
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