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FDA ANDA · ANDA070330

IBUPROFEN

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA070330
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-06
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 41 · standardAP
2021-04-28Labeling · Supplement 40 · standardAP
2019-07-22Labeling · Supplement 39 · standardAP
2016-05-09Labeling · Supplement 38 · standardAP
1998-03-13Manufacturing (CMC) · Supplement 37AP
1997-01-14Manufacturing (CMC) · Supplement 35AP
1994-04-29Manufacturing (CMC) · Supplement 32AP
1994-03-07Manufacturing (CMC) · Supplement 31AP
1992-01-10Labeling · Supplement 30AP
1991-06-11Labeling · Supplement 29AP
1989-03-02Manufacturing (CMC) · Supplement 22AP
1989-03-02Manufacturing (CMC) · Supplement 25AP
1989-03-02Manufacturing (CMC) · Supplement 23AP
1989-02-21Labeling · Supplement 27AP
1988-02-10Manufacturing (CMC) · Supplement 17AP
1988-02-02Manufacturing (CMC) · Supplement 14AP
1988-02-02Manufacturing (CMC) · Supplement 13AP
1987-12-31Manufacturing (CMC) · Supplement 18AP
1987-09-22Manufacturing (CMC) · Supplement 16AP
1987-09-22Manufacturing (CMC) · Supplement 15AP
1987-07-22Manufacturing (CMC) · Supplement 10AP
1986-06-11Manufacturing (CMC) · Supplement 8AP
1986-05-16Manufacturing (CMC) · Supplement 7AP
1985-12-26Manufacturing (CMC) · Supplement 3AP
1985-08-06OriginalAP
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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