← FDA DRUG APPROVALS

FDA ANDA · ANDA074937

IBUPROFEN CHILDRENS

ibuprofen

Sponsor: PERRIGO

APPLICATION
ANDA074937
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-22
LATEST ACTION
2011-05-18
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S IBUPROFENOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL

Approval history

2011-05-18Labeling · Supplement 57AP
2006-03-17Labeling · Supplement 40AP
2002-11-26Manufacturing (CMC) · Supplement 23AP
2002-11-26Manufacturing (CMC) · Supplement 22AP
2002-08-02Labeling · Supplement 24AP
2001-08-21Manufacturing (CMC) · Supplement 20AP
2001-08-03Labeling · Supplement 21AP
2001-07-30Labeling · Supplement 12AP
2001-07-30Manufacturing (CMC) · Supplement 10AP
2001-07-30Manufacturing (CMC) · Supplement 9AP
2001-07-30Labeling · Supplement 7AP
2001-07-30Manufacturing (CMC) · Supplement 5AP
2001-07-30Manufacturing (CMC) · Supplement 19AP
2001-07-30Labeling · Supplement 17AP
2001-07-30Manufacturing (CMC) · Supplement 15AP
2001-07-30Manufacturing (CMC) · Supplement 13AP
2001-07-30Manufacturing (CMC) · Supplement 11AP
2001-07-30Manufacturing (CMC) · Supplement 6AP
2001-07-30Manufacturing (CMC) · Supplement 18AP
2001-07-30Manufacturing (CMC) · Supplement 16AP
2001-07-30Manufacturing (CMC) · Supplement 14AP
2001-03-27Labeling · Supplement 4AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1999-04-26Labeling · Supplement 1AP
1998-12-22Original — Letter ↗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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