MedPath
FDA Approval

ENTOCORT

February 7, 2012

HUMAN PRESCRIPTION DRUG LABEL

Budesonide(3 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (1)

ENTOCORT EC

54868-4910

NDA021324

NDA (C73594)

ORAL

February 7, 2012

Code: Q3OKS62Q6XClass: ACTIBQuantity: 3 mg in 1 1
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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