MedPath
FDA Approval

Kapidex

January 11, 2010

HUMAN PRESCRIPTION DRUG LABEL

Dexlansoprazole(30 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (1)

Kapidex

54868-5998

NDA022287

NDA (C73594)

ORAL

January 11, 2010

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: UYE4T5I70XClass: ACTIBQuantity: 30 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (15 CPS)Inactive
Code: 36SFW2JZ0WClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
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