← FDA DRUG APPROVALS

FDA NDA · NDA017604

FENOPROFEN CALCIUM

Sponsor: PHARMACO

APPLICATION
NDA017604
TYPE
NDA
ORIGINAL APPROVAL
1976-03-16
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NALFON · ReferenceDiscontinued
FENOPROFEN CALCIUM EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
NALFON · ReferenceDiscontinued
FENOPROFEN CALCIUM EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
NALFONDiscontinued
FENOPROFEN CALCIUM EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2024-11-21Labeling · Supplement 54 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 51 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 46 · standard — Label ↗AP
2009-07-21Manufacturing (CMC) · Supplement 43 — Letter ↗AP
2007-08-07Labeling · Supplement 41 · standard — Letter ↗AP
2006-01-18Labeling · Supplement 40 · standard — Label ↗AP
2001-08-21Manufacturing (CMC) · Supplement 38 · priorityAP
1999-11-24Manufacturing (CMC) · Supplement 37 · priorityAP
1998-09-30Manufacturing (CMC) · Supplement 35 · priorityAP
1998-04-02Manufacturing (CMC) · Supplement 33 · priorityAP
1997-12-22Manufacturing (CMC) · Supplement 32 · priorityAP
1996-01-22Manufacturing (CMC) · Supplement 29 · priorityAP
1995-03-29Labeling · Supplement 27AP
1994-04-25Manufacturing (CMC) · Supplement 28 · priorityAP
1987-12-11Manufacturing (CMC) · Supplement 19 · priorityAP
1987-07-23Manufacturing (CMC) · Supplement 23 · priorityAP
1987-07-15Manufacturing (CMC) · Supplement 24 · priorityAP
1986-06-09Labeling · Supplement 22AP
1983-08-09Labeling · Supplement 13AP
1983-08-09Labeling · Supplement 16AP
1983-07-29Manufacturing (CMC) · Supplement 17 · priorityAP
1983-03-31Labeling · Supplement 18AP
1981-07-14Labeling · Supplement 15AP
1980-10-15Efficacy · Supplement 9AP
1980-10-15Manufacturing (CMC) · Supplement 12 · priorityAP
1980-05-06Manufacturing (CMC) · Supplement 14 · priorityAP
1978-10-24Manufacturing (CMC) · Supplement 7 · priorityAP
1977-04-01Manufacturing (CMC) · Supplement 6 · priorityAP
1976-09-23Manufacturing (CMC) · Supplement 3 · priorityAP
1976-03-16Type 1 - New Molecular Entity · Original · priority — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

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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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