Atripla
These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information for ATRIPLA. ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
2096a07e-8601-4bdc-ba5a-338a40cd02e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2013
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.
efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5643
Application NumberNDA021937
Product Classification
M
Marketing Category
C73594
G
Generic Name
efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2013
FDA Product Classification
INGREDIENTS (14)
EFAVIRENZActive
Quantity: 600 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT