Fosamprenavir Calcium
These highlights do not include all the information needed to use FOSAMPRENAVIR CALCIUM TABLETS safely and effectively. See full prescribing information for FOSAMPRENAVIR CALCIUM TABLETS. FOSAMPRENAVIR CALCIUM tablets, for oral useInitial U.S. Approval: 2003
Approved
Approval ID
3a1424d8-844c-4e24-9ebd-b2c2b61b61a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fosamprenavir calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3520
Application NumberANDA204060
Product Classification
M
Marketing Category
C73584
G
Generic Name
fosamprenavir calcium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2019
FDA Product Classification
INGREDIENTS (10)
FOSAMPRENAVIR CALCIUMActive
Quantity: 700 mg in 1 1
Code: ID1GU2627N
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT