Fortical
FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray
Approved
Approval ID
e662c321-8c1b-4829-b4c9-459284f654c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
calcitonin salmon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5499
Application NumberNDA021406
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcitonin salmon
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 3, 2010
FDA Product Classification
INGREDIENTS (9)
CALCITONIN SALMONActive
Quantity: 2200 [iU] in 1 mL
Code: 7SFC6U2VI5
Classification: ACTIB
PHENETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT