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FDA ANDA · ANDA202438

FAMCICLOVIR

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA202438
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-10
LATEST ACTION
2020-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FAMCICLOVIRPrescription
FAMCICLOVIR 250MG · TABLET · ORAL
FAMCICLOVIRPrescription
FAMCICLOVIR 500MG · TABLET · ORAL
FAMCICLOVIRPrescription
FAMCICLOVIR 125MG · TABLET · ORAL

Approval history

2020-09-03Labeling · Supplement 3 · standardAP
2020-09-03Labeling · Supplement 1 · standardAP
2014-09-10UNKNOWN · OriginalAP
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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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