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CALCITONIN SALMON

Calcitonin-SalmonNasal Spray, USPRx OnlyPrescribing Information

Approved
Approval ID

1d20ac74-4cd8-4277-9e43-79df44c26254

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2011

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 Code54868-6323
Application NumberANDA076979
Product Classification
M
Marketing Category
C73584
G
Generic Name
CALCITONIN SALMON
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 12, 2011
FDA Product Classification

INGREDIENTS (5)

CALCITONIN SALMONActive
Quantity: 200 [iU] in 0.09 mL
Code: 7SFC6U2VI5
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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CALCITONIN SALMON - FDA Drug Approval Details