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FDA ANDA · ANDA085261

AMINOPHYLLINE

Sponsor: ANI PHARMS

APPLICATION
ANDA085261
TYPE
ANDA
ORIGINAL APPROVAL
1976-12-22
LATEST ACTION
1995-01-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 100MG · TABLET · ORAL
AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 200MG · TABLET · ORAL

Approval history

1995-01-06Manufacturing (CMC) · Supplement 57AP
1990-12-10Labeling · Supplement 56AP
1989-11-30Labeling · Supplement 54AP
1989-11-30Labeling · Supplement 55AP
1987-06-19Manufacturing (CMC) · Supplement 52AP
1987-06-19Manufacturing (CMC) · Supplement 50AP
1987-06-19Manufacturing (CMC) · Supplement 53AP
1987-06-19Manufacturing (CMC) · Supplement 51AP
1984-08-23Manufacturing (CMC) · Supplement 46AP
1984-08-23Manufacturing (CMC) · Supplement 45AP
1984-02-03Manufacturing (CMC) · Supplement 44AP
1982-11-02Manufacturing (CMC) · Supplement 41AP
1982-05-24Manufacturing (CMC) · Supplement 40AP
1981-12-21Manufacturing (CMC) · Supplement 38AP
1981-12-21Manufacturing (CMC) · Supplement 37AP
1976-12-22OriginalAP
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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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