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FDA NDA · NDA021256

CHIRHOSTIM

human secretin

Sponsor: CHIRHOCLIN

APPLICATION
NDA021256
TYPE
NDA
ORIGINAL APPROVAL
2004-04-09
LATEST ACTION
2017-07-18
ROUTE
INTRAVENOUS
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

CHIRHOSTIM · ReferencePrescription
SECRETIN SYNTHETIC HUMAN 16MCG/VIAL · FOR SOLUTION · INTRAVENOUS
CHIRHOSTIM · ReferencePrescription
SECRETIN SYNTHETIC HUMAN 40MCG/VIAL · FOR SOLUTION · INTRAVENOUS

Approval history

2017-07-18Labeling · Supplement 13 · standard — Label ↗AP
2015-07-28Manufacturing (CMC) · Supplement 12 · priorityAP
2007-06-21Manufacturing (CMC) · Supplement 4 · priority — Letter ↗AP
2007-06-21Labeling · Supplement 2 · standard — Letter ↗AP
2004-09-07Labeling · Supplement 1 · standard — Letter ↗AP
2004-04-09Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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