Calcitriol
CALCITRIOL - calcitriol oral solution Patrin Pharma, Inc.
Approved
Approval ID
c5c37779-0c26-438f-b1ca-61cf9915d233
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2023
Manufacturers
FDA
Patrin Pharma, Inc
DUNS: 806841677
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcitriol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39328-042
Application NumberANDA203973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitriol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2023
FDA Product Classification
INGREDIENTS (4)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
CalcitriolActive
Quantity: 1 ug in 1 mL
Code: FXC9231JVH
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT