← FDA DRUG APPROVALS

FDA NDA · NDA021472

MIDOL LIQUID GELS

Sponsor: BIONPHARMA

APPLICATION
NDA021472
TYPE
NDA
ORIGINAL APPROVAL
2002-10-18
LATEST ACTION
2021-10-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

MIDOL LIQUID GELS · ReferenceOver-the-counter
IBUPROFEN 200MG · CAPSULE · ORAL

Approval history

2021-10-21Labeling · Supplement 15 · standard — Letter ↗AP
2017-03-16Labeling · Supplement 14 · standard — Label ↗AP
2010-04-28Labeling · Supplement 13 · unknown — Letter ↗AP
2009-04-15Labeling · Supplement 12 · standard — Letter ↗AP
2009-02-19Labeling · Supplement 11 · standard — Letter ↗AP
2006-12-18Labeling · Supplement 7 · standard — Letter ↗AP
2006-03-13Efficacy · Supplement 5 · standard — Label ↗AP
2005-12-21Labeling · Supplement 6 · standard — Letter ↗AP
2004-01-22Labeling · Supplement 1 · standard — Label ↗AP
2002-10-18Type 3 - New Dosage Form · Original · standard — 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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