← FDA DRUG APPROVALS

FDA NDA · NDA019194

SYPRINE

trientine hydrochloride

Sponsor: BAUSCH

APPLICATION
NDA019194
TYPE
NDA
ORIGINAL APPROVAL
1985-11-08
LATEST ACTION
2015-03-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SYPRINE · ReferencePrescription
TRIENTINE HYDROCHLORIDE 250MG · CAPSULE · ORAL

Approval history

2015-03-03Manufacturing (CMC) · Supplement 12 · priorityAP
2001-05-10Manufacturing (CMC) · Supplement 7 · priorityAP
2001-01-17Labeling · Supplement 6 · standardAP
2000-02-08Labeling · Supplement 5 · standard — Review ↗AP
1998-02-24Manufacturing (CMC) · Supplement 4 · priorityAP
1994-06-24Manufacturing (CMC) · Supplement 3 · priorityAP
1988-02-16Labeling · Supplement 2AP
1986-10-15Labeling · Supplement 1AP
1985-11-08Type 1 - New Molecular Entity · Original · priority — Review ↗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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