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 use Initial U.S. Approval: 2003
Approved
Approval ID
5cd1eead-9fc1-426c-bee8-214ffa7d9dc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code63304-583
Application NumberANDA204024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosamprenavir Calcium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2019
FDA Product Classification
INGREDIENTS (14)
FOSAMPRENAVIR CALCIUMActive
Quantity: 700 mg in 1 1
Code: ID1GU2627N
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT