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FDA ANDA · ANDA216845

DICLOXACILLIN SODIUM

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA216845
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-23
LATEST ACTION
2022-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DICLOXACILLIN SODIUMPrescription
DICLOXACILLIN SODIUM EQ 500MG BASE · CAPSULE · ORAL
DICLOXACILLIN SODIUMPrescription
DICLOXACILLIN SODIUM EQ 250MG BASE · CAPSULE · ORAL

Approval history

2022-09-23UNKNOWN · Original · standardLetterAP
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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