ATORVASTATIN CALCIUM
These highlights do not include all the information needed to use CALCIUM TABLETS safely and effectively. See full prescribing information for CALCIUM TABLETS. CALCIUM tablets, for oral administration Initial U.S. Approval: 1996
Approved
Approval ID
c019e1e4-b95d-4a5b-a3d7-83989ffa092e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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
NDC Product Code43353-321
Application NumberANDA090548
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 5, 2017
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Atorvastatin Calcium TrihydrateActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM