CALCITONIN SALMON
These highlights do not include all the information needed to use CALCITONIN SALMON NASAL SOLUTION (Calcitonin Salmon Nasal Spray) safely and effectively. See full prescribing information for CALCITONIN SALMON NASAL SOLUTION (Calcitonin Salmon Nasal Spray), for Intranasal Use Only ().Initial U.S. Approval: 1975
Approved
Approval ID
a6eaedb3-5c96-4859-be43-a48c9c818bc7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2019
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code49884-161
Application NumberANDA076979
Product Classification
M
Marketing Category
C73584
G
Generic Name
CALCITONIN SALMON
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 30, 2019
FDA Product Classification
INGREDIENTS (5)
NITROGENInactive
Code: N762921K75
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CALCITONIN SALMONActive
Quantity: 200 [iU] in 0.09 mL
Code: 7SFC6U2VI5
Classification: ACTIB