MedPath
FDA Approval

Fortical

January 15, 2010

HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (1)

Fortical

54868-5499

NDA021406

NDA (C73594)

NASAL

September 3, 2010

Code: 7SFC6U2VI5Class: ACTIBQuantity: 2200 [iU] in 1 mL
PHENETHYL ALCOHOLInactive
Code: ML9LGA7468Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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