← FDA DRUG APPROVALS

FDA NDA · NDA022141

CIMDUO

lamivudine and tenofovir disoproxil fumarate

Sponsor: MYLAN LABS LTD

APPLICATION
NDA022141
TYPE
NDA
ORIGINAL APPROVAL
2018-02-28
LATEST ACTION
2018-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CIMDUO · ReferencePrescription
LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2018-07-10UNKNOWN · Supplement 24 · standard — Letter ↗AP
2018-02-28Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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