SELZENTRY
These highlights do not include all the information needed to use SELZENTRY safely and effectively. See full prescribing information for SELZENTRY. SELZENTRY (maraviroc) TabletsInitial U.S. Approval: 2007
Approved
Approval ID
2b5e5c5d-852a-413b-825c-8491d4539e67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Maraviroc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5809
Application NumberNDA022128
Product Classification
M
Marketing Category
C73594
G
Generic Name
Maraviroc
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2012
FDA Product Classification
INGREDIENTS (12)
MaravirocActive
Quantity: 300 mg in 1 1
Code: MD6P741W8A
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
anhydrous dibasic calcium phosphateInactive
Code: L11K75P92J
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C blue no. 2Inactive
Code: L06K8R7DQK
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
lecithin, soybeanInactive
Code: 1DI56QDM62
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT