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FDA ANDA · ANDA209179

CHILDRENS IBUPROFEN

ibuprofen

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA209179
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-17
LATEST ACTION
2021-06-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

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

Approval history

2021-06-16Manufacturing (CMC) · Supplement 1 · unknownAP
2018-04-17UNKNOWN · Original · standardAP
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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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