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Emtricitabine and tenofovir disoproxil fumarate

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. These highlights do not include all the information needed to use EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2004

Approved
Approval ID

fe0d4bf9-fddd-6722-e053-6294a90aa9f3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 15, 2023

Manufacturers
FDA

Pharmasource Meds, LLC

DUNS: 118772692

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Emtricitabine and tenofovir disoproxil fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82982-068
Application NumberANDA212689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Emtricitabine and tenofovir disoproxil fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification

INGREDIENTS (13)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB

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Emtricitabine and tenofovir disoproxil fumarate - FDA Drug Approval Details