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
ece693d8-1832-4b85-8736-819163ba56c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2017
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 Code42023-205
Application NumberANDA209358
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitonin Salmon
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
CALCITONIN SALMONActive
Quantity: 200 [iU] in 1 mL
Code: 7SFC6U2VI5
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 2.25 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT