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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

a5da2960-d113-4c6a-bb3f-c6ce65731b1f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 18, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code72162-2128
Application NumberANDA076396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitonin Salmon
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 19, 2023
FDA Product Classification

INGREDIENTS (5)

CALCITONIN SALMONActive
Quantity: 200 [iU] in 1 1
Code: 7SFC6U2VI5
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

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Calcitonin Salmon - FDA Drug Approval Details