Calcitonin Salmon
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . nasal sprayInitial U.S. Approval: 1975
Approved
Approval ID
c82eb602-12e1-692b-d660-f8d5b5736b54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-0823
Application NumberANDA076396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitonin Salmon
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (5)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CALCITONIN SALMONActive
Quantity: 200 [iU] in 1 1
Code: 7SFC6U2VI5
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT