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FDA NDA · NDA018714

BILTRICIDE

praziquantel

Sponsor: BAYER HLTHCARE

APPLICATION
NDA018714
TYPE
NDA
ORIGINAL APPROVAL
1982-12-29
LATEST ACTION
2023-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BILTRICIDE · ReferenceDiscontinued
PRAZIQUANTEL 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-12-19Labeling · Supplement 20 · standard — Label ↗AP
2019-01-08Labeling · Supplement 18 · standard — Label ↗AP
2014-11-20Manufacturing (CMC) · Supplement 15 · priorityAP
2014-09-18Manufacturing (CMC) · Supplement 14 · priorityAP
2014-02-25Labeling · Supplement 13 · standard — Label ↗AP
2010-08-16Labeling · Supplement 12 · standard — Label ↗AP
2004-07-14Labeling · Supplement 8 · standard — Label ↗AP
2004-07-14Labeling · Supplement 9 · standard — Letter ↗AP
1989-11-07Manufacturing (CMC) · Supplement 6 · priorityAP
1988-11-09Labeling · Supplement 3AP
1988-08-09Manufacturing (CMC) · Supplement 4 · priorityAP
1988-08-09Manufacturing (CMC) · Supplement 5 · priorityAP
1985-08-20Labeling · Supplement 2AP
1983-05-11Labeling · Supplement 1AP
1982-12-29Type 1 - New Molecular Entity · Original · priorityAP
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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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