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FDA ANDA · ANDA071773

IBUPRIN

Sponsor: PLIVA

APPLICATION
ANDA071773
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-16
LATEST ACTION
1994-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPRINDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

1994-05-11Manufacturing (CMC) · Supplement 7AP
1988-01-11Manufacturing (CMC) · Supplement 3AP
1988-01-11Manufacturing (CMC) · Supplement 2AP
1987-08-27Manufacturing (CMC) · Supplement 1AP
1987-07-16OriginalAP
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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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