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FDA NDA · NDA213876

ALKINDI SPRINKLE

hydrocortisone

Sponsor: ETON

APPLICATION
NDA213876
TYPE
NDA
ORIGINAL APPROVAL
2020-09-29
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

ALKINDI SPRINKLE · ReferencePrescription
HYDROCORTISONE 2MG · GRANULE · ORAL
ALKINDI SPRINKLE · ReferencePrescription
HYDROCORTISONE 0.5MG · GRANULE · ORAL
ALKINDI SPRINKLE · ReferencePrescription
HYDROCORTISONE 5MG · GRANULE · ORAL
ALKINDI SPRINKLE · ReferencePrescription
HYDROCORTISONE 1MG · GRANULE · ORAL

Approval history

2024-06-05Labeling · Supplement 5 · standard — Label ↗AP
2022-12-23Labeling · Supplement 2 · standard — Label ↗AP
2022-02-03Labeling · Supplement 1 · standard — Letter ↗AP
2020-09-29Type 3 - New Dosage Form · Original · standard — Letter ↗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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