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FDA ANDA · ANDA084540

AMINOPHYLLINE

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA084540
TYPE
ANDA
ORIGINAL APPROVAL
1975-11-26
LATEST ACTION
2002-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 100MG · TABLET · ORAL

Approval history

2002-07-18Manufacturing (CMC) · Supplement 40AP
2001-01-25Manufacturing (CMC) · Supplement 38AP
2001-01-25Manufacturing (CMC) · Supplement 39AP
2000-01-13Manufacturing (CMC) · Supplement 37AP
1998-10-01Manufacturing (CMC) · Supplement 36AP
1996-09-24Labeling · Supplement 35AP
1995-05-26Manufacturing (CMC) · Supplement 34AP
1994-06-16Manufacturing (CMC) · Supplement 33AP
1991-06-19Manufacturing (CMC) · Supplement 32AP
1991-04-18Manufacturing (CMC) · Supplement 31AP
1990-09-25Labeling · Supplement 27AP
1989-01-27Manufacturing (CMC) · Supplement 22AP
1988-04-29Manufacturing (CMC) · Supplement 20AP
1988-04-29Manufacturing (CMC) · Supplement 19AP
1988-04-29Manufacturing (CMC) · Supplement 21AP
1988-02-11Manufacturing (CMC) · Supplement 18AP
1985-03-11Manufacturing (CMC) · Supplement 15AP
1984-03-29Manufacturing (CMC) · Supplement 14AP
1984-01-04Manufacturing (CMC) · Supplement 13AP
1982-05-29Manufacturing (CMC) · Supplement 11AP
1975-11-26OriginalAP
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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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