Calcitonin Salmon
These highlights do not include all the information needed to use CALCITONIN SALMON injection safely and effectively. See full prescribing information for CALCITONIN SALMON injection. CALCITONIN SALMON injection, synthetic, for subcutaneous or intramuscular use Initial U.S. Approval: 1975
Approved
Approval ID
7d4507aa-8e10-44a6-bc6e-3176aa8b23cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals)
DUNS: 118707839
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 Code24201-400
Application NumberANDA212416
Product Classification
M
Marketing Category
C73584
G
Generic Name
calcitonin salmon
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
ACETIC ACIDInactive
Quantity: 2.25 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
CALCITONIN SALMONActive
Quantity: 200 [USP'U] in 1 mL
Code: 7SFC6U2VI5
Classification: ACTIB