ATORVASTATIN CALCIUM
Approved
Approval ID
5f4b905e-588e-d760-e053-2991aa0ae134
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2017
Manufacturers
FDA
H.J Harkins Company Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATORVASTATIN CALCIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76519-1063
Application NumberANDA091624
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATORVASTATIN CALCIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2017
FDA Product Classification
INGREDIENTS (1)
ATORVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM