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FDA NDA · NDA020135

MOTRIN

Sponsor: MCNEIL PED

APPLICATION
NDA020135
TYPE
NDA
ORIGINAL APPROVAL
1994-11-16
LATEST ACTION
2002-08-05
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

MOTRINDiscontinued
IBUPROFEN 100MG · TABLET, CHEWABLE · ORAL
MOTRINDiscontinued
IBUPROFEN 50MG · TABLET, CHEWABLE · ORAL

Approval history

2002-08-05Manufacturing (CMC) · Supplement 7 · standardAP
2002-02-04Labeling · Supplement 5 · standard — Review ↗AP
2001-05-14Manufacturing (CMC) · Supplement 6 · standardAP
1996-01-02Manufacturing (CMC) · Supplement 2 · standardAP
1995-03-24Efficacy · Supplement 1 · standardAP
1994-11-16Type 3 - New Dosage Form · Original · standardAP
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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