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FDA ANDA · ANDA090410

BUDESONIDE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA090410
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-16
LATEST ACTION
2021-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

BUDESONIDEPrescription
BUDESONIDE 3MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2021-07-29Labeling · Supplement 12 · standardAP
2021-07-29Labeling · Supplement 10 · standardAP
2021-07-29Labeling · Supplement 9 · standardAP
2021-07-29Manufacturing (CMC) · Supplement 15AP
2016-01-03Labeling · Supplement 7 · standardAP
2011-05-16Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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