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FDA ANDA · ANDA077673

EFAVIRENZ

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA077673
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-21
LATEST ACTION
2024-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EFAVIRENZPrescription
EFAVIRENZ 600MG · TABLET · ORAL

Approval history

2024-06-18Labeling · Supplement 21 · standardAP
2020-02-04Labeling · Supplement 16 · standardAP
2018-09-21OriginalLetterAP
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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