← FDA DRUG APPROVALS

FDA NDA · NDA210455

SYMTUZA

darunavir, cobicistat, emtricitabine, and tenofovir alafenamide

Sponsor: JANSSEN PRODS

APPLICATION
NDA210455
TYPE
NDA
ORIGINAL APPROVAL
2018-07-17
LATEST ACTION
2023-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SYMTUZA · ReferencePrescription
COBICISTAT 150MG, DARUNAVIR 800MG, EMTRICITABINE 200MG, TENOFOVIR ALAFENAMIDE FUMARATE EQ 10MG BASE · TABLET · ORAL

Approval history

2023-03-31Labeling · Supplement 23 · standard — Label ↗AP
2022-10-20Labeling · Supplement 22 · standard — Letter ↗AP
2022-04-14Labeling · Supplement 20 · standard — Letter ↗AP
2021-07-29Labeling · Supplement 16 · standard — Label ↗AP
2021-06-28Labeling · Supplement 17 · standard — Label ↗AP
2020-12-22Labeling · Supplement 12 · standard — Letter ↗AP
2020-03-02Efficacy · Supplement 9 · standard — Label ↗AP
2019-05-30Labeling · Supplement 4 · standard — Label ↗AP
2019-02-25Labeling · Supplement 5 · standard — Label ↗AP
2019-01-25Labeling · Supplement 1 · standard — Label ↗AP
2018-07-17Type 4 - New Combination · Original · standard — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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