CRIXIVAN
CRIXIVAN (INDINAVIR SULFATE)CAPSULES
Approved
Approval ID
83aeddf8-6fed-487c-858b-2240f0a0e8af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
INDINAVIR SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-064
Application NumberNDA020685
Product Classification
M
Marketing Category
C73594
G
Generic Name
INDINAVIR SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2012
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
INDINAVIR SULFATEActive
Quantity: 400 mg in 1 1
Code: 771H53976Q
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT