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Emtriva

These highlights do not include all the information needed to use EMTRIVA safely and effectively. See full prescribing information for EMTRIVA.EMTRIVA (emtricitabine) capsule for oral useEMTRIVA (emtricitabine) solution for oral useInitial U.S. Approval: 2003

Approved
Approval ID

d99086c9-41a4-4c69-b41a-80054e828095

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 10, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 1

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

emtricitabine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0801
Application NumberNDA021500
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine
Product Specifications
Route of AdministrationORAL
Effective DateMay 10, 2010
FDA Product Classification

INGREDIENTS (1)

EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB

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Emtriva - FDA Drug Approval Details