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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

946b680e-34e2-4789-8a9f-c00f851ad033

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 1, 2009

Manufacturers
FDA

Excella GmbH

DUNS: 329809800

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 Code46014-0601
Application NumberNDA021500
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2009
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