APPLICATION
ANDA078064
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-15
LATEST ACTION
2024-06-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
EFAVIRENZPrescription
EFAVIRENZ 200MG · CAPSULE · ORAL
EFAVIRENZPrescription
EFAVIRENZ 50MG · CAPSULE · ORAL
EFAVIRENZPrescription
EFAVIRENZ 100MG · CAPSULE · ORAL
Approval history
2024-06-20Labeling · Supplement 17 · standardAP
2020-02-04Labeling · Supplement 14 · standardAP
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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