Invirase
These highlights do not include all the information needed to use INVIRASE safely and effectively. See full prescribing information for INVIRASE. INVIRASE (saquinavir mesylate) tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
c00d1607-ac36-457b-a34b-75ad74f9cf0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2021
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
saquinavir mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0004-0244
Application NumberNDA021785
Product Classification
M
Marketing Category
C73594
G
Generic Name
saquinavir mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2019
FDA Product Classification
INGREDIENTS (12)
SAQUINAVIR MESYLATEActive
Quantity: 500 mg in 1 1
Code: UHB9Z3841A
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT